510(k) K081549 ยท NTE Temporary Carotid Catheter For Embolic Capture
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
| Applicant | Abbott Laboratories, Santa Clara CA, US |
| Decision | Substantially Equivalent, Aug 19, 2008 |
| Received | Jun 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081549
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2013 | Abbott Vascular Brand Name: RX Accunet Embolic Protection System
Common Name: RX Accunet EPS.
Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55.
The RX Accu Terminated |
NTE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.