510(k) K052166 ยท NTE Temporary Carotid Catheter For Embolic Capture
MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM
| Applicant | Guidant Corporation, Santa Clara CA, US |
| Decision | Substantially Equivalent, Aug 18, 2005 |
| Received | Aug 9, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052166
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.