Silk Road Medical
Plymouth, MN, US
Silk Road Medical appears in FDA device records in Plymouth, MN. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Silk Road Medical between 2013 and 2023. The busiest year on record is 2015, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230402 | ENROUTE® Transcarotid Neuroprotection System | NTE | Substantially Equivalent | |
| K221414 | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | LIT | Substantially Equivalent | |
| K153485 | ENROUTE Transcarotid Neuroprotection System | NTE | Substantially Equivalent | |
| K143459 | Silk Road Acccess Catheter | DQY | Substantially Equivalent | |
| K143072 | ENROUTE Transcarotid Neuroprotection System | NTE | Substantially Equivalent | |
| K130649 | SILK ROAD ACCESS CATHETER | DQY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3022627847 | 3022627847 | Silk Road Medical | 14755 27th Avenue North, Plymouth, MN 55447 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Silk Road Medical edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain