510(k) K182916 ยท MJN Catheter, Intravascular Occluding, Temporary
Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr
| Applicant | Lemaitre Vascular, Burlington MA, US |
| Decision | Substantially Equivalent, Nov 16, 2018 |
| Received | Oct 18, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182916
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.