Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

ADVANTA SLIDER GDS

Model 22279 · Atrium Medical Corporation · DI 00650862222791

DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · Class II · 21 CFR 870.3450

DWS — Instruments, Surgical, Cardiovascular · Class I · 21 CFR 870.4500

UDILibrary device dossier · generated 2026-09-06 · 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 2.43/device2019-02: 0 reports for this device; peer average 3.17/device2019-03: 0 reports for this device; peer average 2.33/device2019-04: 0 reports for this device; peer average 2.71/device2019-05: 0 reports for this device; peer average 2.09/device2019-06: 0 reports for this device; peer average 1.83/device2019-07: 0 reports for this device; peer average 2.06/device2019-08: 0 reports for this device; peer average 4.92/device2019-09: 0 reports for this device; peer average 2.15/device2019-10: 0 reports for this device; peer average 3.68/device2019-11: 0 reports for this device; peer average 3.75/device2019-12: 0 reports for this device; peer average 3.11/device2020-01: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 2.14/device2020-03: 0 reports for this device; peer average 3.13/device2020-04: 0 reports for this device; peer average 2.43/device2020-05: 0 reports for this device; peer average 4.29/device2020-06: 0 reports for this device; peer average 3/device2020-07: 0 reports for this device; peer average 2.75/device2020-08: 0 reports for this device; peer average 2.11/device2020-09: 0 reports for this device; peer average 1.86/device2020-10: 0 reports for this device; peer average 2.63/device2020-11: 0 reports for this device; peer average 2.64/device2020-12: 0 reports for this device; peer average 2.38/device2021-01: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 2.67/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 2.54/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 3.14/device2021-07: 0 reports for this device; peer average 3.6/device2021-08: 0 reports for this device; peer average 1.56/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 2.67/device2021-11: 0 reports for this device; peer average 1.87/device2021-12: 0 reports for this device; peer average 2.58/device2022-01: 0 reports for this device; peer average 1.71/device2022-02: 0 reports for this device; peer average 2.67/device2022-03: 0 reports for this device; peer average 4.14/device2022-04: 0 reports for this device; peer average 2.5/device2022-05: 0 reports for this device; peer average 2.5/device2022-06: 0 reports for this device; peer average 4.31/device2022-07: 0 reports for this device; peer average 1.88/device2022-08: 0 reports for this device; peer average 3.5/device2022-09: 0 reports for this device; peer average 2.17/device2022-10: 0 reports for this device; peer average 2.6/device2022-11: 0 reports for this device; peer average 3.11/device2022-12: 0 reports for this device; peer average 3.6/device2023-01: 0 reports for this device; peer average 1.6/device2023-02: 0 reports for this device; peer average 3.13/device2023-03: 0 reports for this device; peer average 4.5/device2023-04: 0 reports for this device; peer average 4.14/device2023-05: 0 reports for this device; peer average 4/device2023-06: 0 reports for this device; peer average 3.4/device2023-07: 0 reports for this device; peer average 4.67/device2023-08: 0 reports for this device; peer average 2.48/device2023-09: 0 reports for this device; peer average 2.75/device2023-10: 0 reports for this device; peer average 2.22/device2023-11: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 2.4/device2024-01: 0 reports for this device; peer average 3.15/device2024-02: 0 reports for this device; peer average 3.73/device2024-03: 0 reports for this device; peer average 3.31/device2024-04: 0 reports for this device; peer average 1.86/device2024-05: 0 reports for this device; peer average 1.5/device2024-06: 0 reports for this device; peer average 3.9/device2024-07: 0 reports for this device; peer average 2.1/device2024-08: 0 reports for this device; peer average 2.38/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 1.83/device2024-11: 0 reports for this device; peer average 1.42/device2024-12: 0 reports for this device; peer average 2.13/device2025-01: 0 reports for this device; peer average 2.31/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1.83/device2025-04: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 3.71/device2025-06: 0 reports for this device; peer average 1.86/device2025-07: 0 reports for this device; peer average 4.57/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1.14/device2025-10: 0 reports for this device; peer average 3/device2025-11: 0 reports for this device; peer average 2.75/device2025-12: 0 reports for this device; peer average 2.33/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 1.8/device2026-03: 0 reports for this device; peer average 3.07/device2026-04: 0 reports for this device; peer average 5.07/device2026-05: 0 reports for this device; peer average 3.11/device2026-06: 0 reports for this device; peer average 4/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.43
2019-0203.17
2019-0302.33
2019-0402.71
2019-0502.09
2019-0601.83
2019-0702.06
2019-0804.92
2019-0902.15
2019-1003.68
2019-1103.75
2019-1203.11
2020-0103
2020-0202.14
2020-0303.13
2020-0402.43
2020-0504.29
2020-0603
2020-0702.75
2020-0802.11
2020-0901.86
2020-1002.63
2020-1102.64
2020-1202.38
2021-0102
2021-0202.67
2021-0302
2021-0402.54
2021-0502
2021-0603.14
2021-0703.6
2021-0801.56
2021-0902
2021-1002.67
2021-1101.87
2021-1202.58
2022-0101.71
2022-0202.67
2022-0304.14
2022-0402.5
2022-0502.5
2022-0604.31
2022-0701.88
2022-0803.5
2022-0902.17
2022-1002.6
2022-1103.11
2022-1203.6
2023-0101.6
2023-0203.13
2023-0304.5
2023-0404.14
2023-0504
2023-0603.4
2023-0704.67
2023-0802.48
2023-0902.75
2023-1002.22
2023-1101.5
2023-1202.4
2024-0103.15
2024-0203.73
2024-0303.31
2024-0401.86
2024-0501.5
2024-0603.9
2024-0702.1
2024-0802.38
2024-0902
2024-1001.83
2024-1101.42
2024-1202.13
2025-0102.31
2025-0201
2025-0301.83
2025-0402
2025-0503.71
2025-0601.86
2025-0704.57
2025-0802
2025-0901.14
2025-1003
2025-1102.75
2025-1202.33
2026-0102
2026-0201.8
2026-0303.07
2026-0405.07
2026-0503.11
2026-0604
This device (reports/month)Average device in DSY, DWS (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Atrium Medical Corporation

  • Warning Letter 2012-10-11 Atrium Medical Corporation
  • Warning Letter 2012-10-11 Atrium Medical Corporation
  • VAI 2024-11-26 Atrium Medical Corporation · 8 citations
  • VAI 2024-11-26 Atrium Medical Corporation · 8 citations
  • VAI 2022-09-06 Atrium Medical Corporation · 0 citations
  • VAI 2022-09-06 Atrium Medical Corporation · 0 citations
  • OAI 2020-02-10 Atrium Medical Corporation · 0 citations
  • OAI 2020-02-10 Atrium Medical Corporation · 0 citations
  • NAI 2018-08-02 Atrium Medical Corporation · 0 citations
  • NAI 2018-08-02 Atrium Medical Corporation · 0 citations
  • OAI 2016-07-13 Atrium Medical Corporation · 0 citations
  • OAI 2016-07-13 Atrium Medical Corporation · 0 citations
  • NAI 2016-01-08 Atrium Medical Corporation · 0 citations
  • NAI 2016-01-08 Atrium Medical Corporation · 0 citations
  • OAI 2013-10-01 Atrium Medical Corporation · 8 citations
  • OAI 2013-10-01 Atrium Medical Corporation · 8 citations
  • OAI 2012-09-07 Atrium Medical Corporation · 5 citations
  • OAI 2012-09-07 Atrium Medical Corporation · 5 citations
  • VAI 2010-03-15 Atrium Medical Corporation · 0 citations
  • VAI 2010-03-15 Atrium Medical Corporation · 0 citations