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Model IPN930602 · TELEFLEX INCORPORATED · DI 10801902222135

LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days · Class II · 21 CFR 880.5970

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

13452019-01: 0 reports for this device; peer average 3.49/device2019-02: 0 reports for this device; peer average 3.51/device2019-03: 0 reports for this device; peer average 2.8/device2019-04: 0 reports for this device; peer average 3.52/device2019-05: 0 reports for this device; peer average 3.68/device2019-06: 0 reports for this device; peer average 3.14/device2019-07: 0 reports for this device; peer average 3.77/device2019-08: 0 reports for this device; peer average 3.83/device2019-09: 0 reports for this device; peer average 3.28/device2019-10: 0 reports for this device; peer average 4.5/device2019-11: 0 reports for this device; peer average 3.51/device2019-12: 0 reports for this device; peer average 3.51/device2020-01: 0 reports for this device; peer average 4.57/device2020-02: 0 reports for this device; peer average 3.84/device2020-03: 0 reports for this device; peer average 3.56/device2020-04: 0 reports for this device; peer average 3.89/device2020-05: 0 reports for this device; peer average 4.29/device2020-06: 0 reports for this device; peer average 4.44/device2020-07: 0 reports for this device; peer average 5.25/device2020-08: 0 reports for this device; peer average 4.21/device2020-09: 0 reports for this device; peer average 3.98/device2020-10: 0 reports for this device; peer average 2.69/device2020-11: 0 reports for this device; peer average 2.28/device2020-12: 0 reports for this device; peer average 2.04/device2021-01: 0 reports for this device; peer average 2.4/device2021-02: 0 reports for this device; peer average 2.41/device2021-03: 0 reports for this device; peer average 2.88/device2021-04: 0 reports for this device; peer average 2.61/device2021-05: 0 reports for this device; peer average 2.26/device2021-06: 0 reports for this device; peer average 2.3/device2021-07: 0 reports for this device; peer average 2.76/device2021-08: 0 reports for this device; peer average 2.69/device2021-09: 0 reports for this device; peer average 3.36/device2021-10: 0 reports for this device; peer average 3.12/device2021-11: 0 reports for this device; peer average 4.02/device2021-12: 0 reports for this device; peer average 3.19/device2022-01: 0 reports for this device; peer average 2.36/device2022-02: 0 reports for this device; peer average 3.05/device2022-03: 0 reports for this device; peer average 3.41/device2022-04: 0 reports for this device; peer average 3.03/device2022-05: 0 reports for this device; peer average 2.75/device2022-06: 0 reports for this device; peer average 3/device2022-07: 0 reports for this device; peer average 4.86/device2022-08: 0 reports for this device; peer average 2.91/device2022-09: 0 reports for this device; peer average 3.08/device2022-10: 0 reports for this device; peer average 1.97/device2022-11: 0 reports for this device; peer average 2.77/device2022-12: 0 reports for this device; peer average 2.6/device2023-01: 0 reports for this device; peer average 3.35/device2023-02: 0 reports for this device; peer average 2.59/device2023-03: 0 reports for this device; peer average 2.22/device2023-04: 0 reports for this device; peer average 2.41/device2023-05: 0 reports for this device; peer average 2.87/device2023-06: 0 reports for this device; peer average 2.46/device2023-07: 0 reports for this device; peer average 2.95/device2023-08: 0 reports for this device; peer average 2.82/device2023-09: 0 reports for this device; peer average 2.85/device2023-10: 0 reports for this device; peer average 2.53/device2023-11: 0 reports for this device; peer average 2.11/device2023-12: 0 reports for this device; peer average 2.37/device2024-01: 0 reports for this device; peer average 2.63/device2024-02: 0 reports for this device; peer average 2.52/device2024-03: 0 reports for this device; peer average 2.32/device2024-04: 0 reports for this device; peer average 2.75/device2024-05: 0 reports for this device; peer average 2.68/device2024-06: 0 reports for this device; peer average 2.95/device2024-07: 0 reports for this device; peer average 2.41/device2024-08: 0 reports for this device; peer average 2.49/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 2.46/device2024-11: 0 reports for this device; peer average 2.71/device2024-12: 0 reports for this device; peer average 2.1/device2025-01: 0 reports for this device; peer average 2.58/device2025-02: 0 reports for this device; peer average 2.14/device2025-03: 0 reports for this device; peer average 2.41/device2025-04: 0 reports for this device; peer average 1.73/device2025-05: 0 reports for this device; peer average 2.26/device2025-06: 0 reports for this device; peer average 2.08/device2025-07: 0 reports for this device; peer average 2.89/device2025-08: 0 reports for this device; peer average 2.48/device2025-09: 0 reports for this device; peer average 2.69/device2025-10: 0 reports for this device; peer average 2.46/device2025-11: 0 reports for this device; peer average 2.68/device2025-12: 0 reports for this device; peer average 2.61/device2026-01: 0 reports for this device; peer average 2.82/device2026-02: 0 reports for this device; peer average 2.75/device2026-03: 0 reports for this device; peer average 2.19/device2026-04: 0 reports for this device; peer average 2.99/device2026-05: 0 reports for this device; peer average 2.46/device2026-06: 0 reports for this device; peer average 2.96/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.49
2019-0203.51
2019-0302.8
2019-0403.52
2019-0503.68
2019-0603.14
2019-0703.77
2019-0803.83
2019-0903.28
2019-1004.5
2019-1103.51
2019-1203.51
2020-0104.57
2020-0203.84
2020-0303.56
2020-0403.89
2020-0504.29
2020-0604.44
2020-0705.25
2020-0804.21
2020-0903.98
2020-1002.69
2020-1102.28
2020-1202.04
2021-0102.4
2021-0202.41
2021-0302.88
2021-0402.61
2021-0502.26
2021-0602.3
2021-0702.76
2021-0802.69
2021-0903.36
2021-1003.12
2021-1104.02
2021-1203.19
2022-0102.36
2022-0203.05
2022-0303.41
2022-0403.03
2022-0502.75
2022-0603
2022-0704.86
2022-0802.91
2022-0903.08
2022-1001.97
2022-1102.77
2022-1202.6
2023-0103.35
2023-0202.59
2023-0302.22
2023-0402.41
2023-0502.87
2023-0602.46
2023-0702.95
2023-0802.82
2023-0902.85
2023-1002.53
2023-1102.11
2023-1202.37
2024-0102.63
2024-0202.52
2024-0302.32
2024-0402.75
2024-0502.68
2024-0602.95
2024-0702.41
2024-0802.49
2024-0902
2024-1002.46
2024-1102.71
2024-1202.1
2025-0102.58
2025-0202.14
2025-0302.41
2025-0401.73
2025-0502.26
2025-0602.08
2025-0702.89
2025-0802.48
2025-0902.69
2025-1002.46
2025-1102.68
2025-1202.61
2026-0102.82
2026-0202.75
2026-0302.19
2026-0402.99
2026-0502.46
2026-0602.96
This device (reports/month)Average device in LJS (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K220363 — cites (transitively): K160925 (d1), K163443 (d1), K140345 (d2), K141634 (d2), K152261 (d2), K070907 (d2), K152899 (d2), K113808 (d3), K973371 (d3), K142889 (d3), K120321 (d3), K133833 (d3), K091324 (d4), K043535 (d4), K132304 (d4), K130499 (d5)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — TELEFLEX INCORPORATED

  • NAI 2026-01-15 Teleflex Medical OEM LLC · 0 citations
  • NAI 2024-03-18 Teleflex LLC (NADC) · 0 citations
  • NAI 2024-03-18 Teleflex LLC (NADC) · 0 citations
  • NAI 2024-01-26 Teleflex Medical OEM LLC · 0 citations
  • NAI 2022-12-09 Teleflex Medical de Tecate, S. de R.L de C.V. (A Teleflex Medical Company) · 0 citations
  • VAI 2022-08-26 TELEFLEX LLC · 3 citations
  • VAI 2022-08-26 TELEFLEX LLC · 3 citations
  • NAI 2021-09-02 TELEFLEX LLC · 0 citations
  • NAI 2021-09-02 TELEFLEX LLC · 0 citations
  • VAI 2021-07-30 Teleflex LLC (NADC) · 4 citations
  • NAI 2017-09-21 Teleflex LLC · 0 citations
  • VAI 2017-09-20 Teleflex Medical, Inc. · 1 citations
  • NAI 2017-02-02 Teleflex Medical OEM LLC · 0 citations
  • NAI 2016-08-29 Teleflex Medical OEM LLC · 0 citations
  • NAI 2016-03-03 Teleflex LLC (NADC) · 0 citations
  • NAI 2016-03-03 Teleflex LLC (NADC) · 0 citations
  • NAI 2015-08-13 Teleflex Medical Sdn. Bhd. · 0 citations
  • NAI 2015-06-05 Teleflex Medical Europe Ltd · 0 citations
  • NAI 2015-02-25 Teleflex Medical Europe, Ltd. · 0 citations
  • NAI 2014-08-28 TELEFLEX LLC · 0 citations