Silk Road Medical, Inc.: FDA clearances and approvals
Silk Road Medical, Inc. has 6 FDA 510(k) clearances (first 2013, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time: 107 days. openFDA lists 1 product recall by a recalling firm named Silk Road Medical, Inc. It is the industry lead sponsor of 5 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 235 |
| 2014 | 0 | — |
| 2015 | 2 | 112 |
| 2016 | 1 | 98 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 109 |
| 2023 | 1 | 55 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Silk Road Medical, Inc.'s cleared 510(k)s took a median 82 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NTE | Temporary Carotid Catheter For Embolic Capture | 3 | 3 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Silk Road Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230402 | ENROUTE® Transcarotid Neuroprotection System | NTE | 2023-04-11 | 55 |
| K221414 | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | LIT | 2022-09-02 | 109 |
| K153485 | ENROUTE Transcarotid Neuroprotection System | NTE | 2016-03-10 | 98 |
| K143459 | Silk Road Acccess Catheter | DQY | 2015-04-01 | 118 |
| K143072 | ENROUTE Transcarotid Neuroprotection System | NTE | 2015-02-09 | 105 |
| K130649 | SILK ROAD ACCESS CATHETER | DQY | 2013-11-01 | 235 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-01-13.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Silk Road Medical, Inc. is the industry lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03985774: The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study (Completed, started 2015-02-26)
- NCT01877174: MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study) (Completed, started 2013-05)
- NCT01685567: Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (Completed, started 2012-11)
- NCT01958294: The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study) (Completed, started 2011-08)
- NCT01264419: Silk Road Medical First in Man Study - Neuroprotection During Carotid Stenting and Angioplasty (Completed, started 2009-03)
Frequently asked questions
How many FDA 510(k) clearances does Silk Road Medical, Inc. have?
Silk Road Medical, Inc. has 6 FDA 510(k) clearances (first 2013, latest 2023), across 3 product codes in 1 review panel.
How long does FDA take to clear Silk Road Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Silk Road Medical, Inc.'s cleared 510(k)s is 107 days.
What devices does Silk Road Medical, Inc. make?
Its most frequent FDA product codes are NTE (Temporary Carotid Catheter For Embolic Capture, 3); DQY (Catheter, Percutaneous, 2); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 1).
Has Silk Road Medical, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Silk Road Medical, Inc; the most recent began 2021-01-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Silk Road Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NTE, Silk Road Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.