510(k) K082755 ยท MAV Syringe, Balloon Inflation
SEDAT FLAMINGO
| Applicant | Sedat, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 15, 2008 |
| Received | Sep 19, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082755
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2014 | Perouse Medical Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter. Terminated |
MAV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.