510(k) K221414 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
| Applicant | Silk Road Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 2, 2022 |
| Received | May 16, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221414
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.