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ENROUTE Transcarotid Neuroprotection System

Model SR-200-NPS · Silk Road Medical, Inc. · DI 00811311020744

NTE — Temporary Carotid Catheter For Embolic Capture · Class II · 21 CFR 870.1250

UDILibrary device dossier · generated 2026-09-12 · 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 (1438)

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.

Injury: 1415 · Malfunction: 17 · Death: 6

142943572019-01: 0 reports for this device; peer average 1.33/device2019-02: 2 reports for this device; peer average 1.6/device2019-03: 22 reports for this device; peer average 8.8/device2019-04: 6 reports for this device; peer average 2.5/device2019-05: 14 reports for this device; peer average 5.43/device2019-06: 8 reports for this device; peer average 3.5/device2019-07: 16 reports for this device; peer average 7/device2019-08: 7 reports for this device; peer average 3.33/device2019-09: 16 reports for this device; peer average 6.5/device2019-10: 10 reports for this device; peer average 4.38/device2019-11: 8 reports for this device; peer average 5/device2019-12: 2 reports for this device; peer average 3/device2020-01: 57 reports for this device; peer average 26.25/device2020-02: 14 reports for this device; peer average 9.5/device2020-03: 12 reports for this device; peer average 6.8/device2020-04: 4 reports for this device; peer average 2.57/device2020-05: 4 reports for this device; peer average 5.67/device2020-06: 6 reports for this device; peer average 3.5/device2020-07: 12 reports for this device; peer average 5.11/device2020-08: 4 reports for this device; peer average 5/device2020-09: 24 reports for this device; peer average 8/device2020-10: 6 reports for this device; peer average 3.13/device2020-11: 16 reports for this device; peer average 7.29/device2020-12: 16 reports for this device; peer average 9.67/device2021-01: 12 reports for this device; peer average 6.2/device2021-02: 14 reports for this device; peer average 7.17/device2021-03: 18 reports for this device; peer average 11.5/device2021-04: 30 reports for this device; peer average 12/device2021-05: 20 reports for this device; peer average 8.33/device2021-06: 32 reports for this device; peer average 13.17/device2021-07: 28 reports for this device; peer average 11.17/device2021-08: 22 reports for this device; peer average 13/device2021-09: 20 reports for this device; peer average 10.33/device2021-10: 30 reports for this device; peer average 11.33/device2021-11: 26 reports for this device; peer average 16.2/device2021-12: 22 reports for this device; peer average 12.4/device2022-01: 26 reports for this device; peer average 15.2/device2022-02: 10 reports for this device; peer average 9.6/device2022-03: 28 reports for this device; peer average 9.86/device2022-04: 14 reports for this device; peer average 7.67/device2022-05: 28 reports for this device; peer average 23.67/device2022-06: 22 reports for this device; peer average 11.2/device2022-07: 24 reports for this device; peer average 13.8/device2022-08: 26 reports for this device; peer average 11.63/device2022-09: 24 reports for this device; peer average 10.83/device2022-10: 20 reports for this device; peer average 8.71/device2022-11: 34 reports for this device; peer average 12.5/device2022-12: 26 reports for this device; peer average 13/device2023-01: 20 reports for this device; peer average 6/device2023-02: 24 reports for this device; peer average 11.67/device2023-03: 27 reports for this device; peer average 14.8/device2023-04: 30 reports for this device; peer average 16.5/device2023-05: 20 reports for this device; peer average 11.2/device2023-06: 20 reports for this device; peer average 8.5/device2023-07: 34 reports for this device; peer average 17/device2023-08: 20 reports for this device; peer average 6.38/device2023-09: 30 reports for this device; peer average 14.6/device2023-10: 30 reports for this device; peer average 17.25/device2023-11: 27 reports for this device; peer average 12.2/device2023-12: 30 reports for this device; peer average 13.5/device2024-01: 34 reports for this device; peer average 13.83/device2024-02: 28 reports for this device; peer average 17.5/device2024-03: 28 reports for this device; peer average 11.5/device2024-04: 24 reports for this device; peer average 10/device2024-05: 28 reports for this device; peer average 14.4/device2024-06: 20 reports for this device; peer average 8.86/device2024-07: 13 reports for this device; peer average 10.57/device2024-08: 11 reports for this device; peer average 9.29/device2024-09: 13 reports for this device; peer average 9/device2024-10: 10 reports for this device; peer average 6.89/device2024-11: 10 reports for this device; peer average 10.5/device2024-12: 4 reports for this device; peer average 4/device2025-01: 5 reports for this device; peer average 7.14/device2025-02: 5 reports for this device; peer average 5.17/device2025-03: 5 reports for this device; peer average 6/device2025-04: 5 reports for this device; peer average 5.75/device2025-05: 3 reports for this device; peer average 4.17/device2025-06: 12 reports for this device; peer average 8.33/device2025-07: 0 reports for this device; peer average 5/device2025-08: 0 reports for this device; peer average 5/device2025-09: 0 reports for this device; peer average 4.86/device2025-10: 0 reports for this device; peer average 7/device2025-11: 0 reports for this device; peer average 5.2/device2025-12: 0 reports for this device; peer average 4.7/device2026-01: 0 reports for this device; peer average 10.5/device2026-02: 0 reports for this device; peer average 3.33/device2026-03: 0 reports for this device; peer average 6.38/device2026-04: 0 reports for this device; peer average 4.25/device2026-05: 23 reports for this device; peer average 6.88/device2026-06: 3 reports for this device; peer average 3.63/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.33
2019-0221.6
2019-03228.8
2019-0462.5
2019-05145.43
2019-0683.5
2019-07167
2019-0873.33
2019-09166.5
2019-10104.38
2019-1185
2019-1223
2020-015726.25
2020-02149.5
2020-03126.8
2020-0442.57
2020-0545.67
2020-0663.5
2020-07125.11
2020-0845
2020-09248
2020-1063.13
2020-11167.29
2020-12169.67
2021-01126.2
2021-02147.17
2021-031811.5
2021-043012
2021-05208.33
2021-063213.17
2021-072811.17
2021-082213
2021-092010.33
2021-103011.33
2021-112616.2
2021-122212.4
2022-012615.2
2022-02109.6
2022-03289.86
2022-04147.67
2022-052823.67
2022-062211.2
2022-072413.8
2022-082611.63
2022-092410.83
2022-10208.71
2022-113412.5
2022-122613
2023-01206
2023-022411.67
2023-032714.8
2023-043016.5
2023-052011.2
2023-06208.5
2023-073417
2023-08206.38
2023-093014.6
2023-103017.25
2023-112712.2
2023-123013.5
2024-013413.83
2024-022817.5
2024-032811.5
2024-042410
2024-052814.4
2024-06208.86
2024-071310.57
2024-08119.29
2024-09139
2024-10106.89
2024-111010.5
2024-1244
2025-0157.14
2025-0255.17
2025-0356
2025-0455.75
2025-0534.17
2025-06128.33
2025-0705
2025-0805
2025-0904.86
2025-1007
2025-1105.2
2025-1204.7
2026-01010.5
2026-0203.33
2026-0306.38
2026-0404.25
2026-05236.88
2026-0633.63
This device (reports/month)Average device in NTE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Silk Road Medical, Inc.

  • VAI 2024-01-23 Silk Road Medical · 1 citations
  • NAI 2023-10-18 Silk Road Medical Inc · 0 citations
  • VAI 2020-02-27 Silk Road Medical Inc · 1 citations
  • NAI 2016-10-03 Silk Road Medical Inc · 0 citations
  • NAI 2016-06-23 Silk Road Medical Inc · 0 citations
  • VAI 2015-04-14 Silk Road Medical Inc · 1 citations
  • NAI 2014-07-11 Silk Road Medical Inc · 0 citations