Total clearances
2
2022-09-02 → 2023-04-11
Name variants in FDA filings: Silk Road Medical, Inc. / Silk Road Medical
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| NTE |
— |
— |
— |
1 |
2023-04-11 |
| LIT |
Catheter, Angioplasty, Peripheral, Transluminal |
Class II |
Cardiovascular |
1 |
2022-09-02 |
Safety
Recalls (1)
Class I (serious)
0
Risk of injury / death
| Date | Severity | Status | Recall # |
Product | Code | Reason |
| 2021-01-13 |
Class II
|
Terminated |
Z-1146-2021 |
ENROUTE Transcarotid Stent System REF SR-XXYY-CS |
— |
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System. |
Filings
All 510(k) clearances (2)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2023-04-11 |
K230402 |
ENROUTE® Transcarotid Neuroprotection System |
NTE |
— |
— |
| 2022-09-02 |
K221414 |
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter |
LIT |
Class II |
Cardiovascular |