510(k) K152833 ยท MJN Catheter, Intravascular Occluding, Temporary
Pruitt F3-S Polyurethane Carotid Shunt
| Applicant | LeMaitre Vascular, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Jan 21, 2016 |
| Received | Sep 29, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152833
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2018 | LeMaitre Vascular, Inc. LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile
Model # 2014-10 Terminated |
MJN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.