510(k) K042218 ยท NTE Temporary Carotid Catheter For Embolic Capture
ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM
| Applicant | Guidant Corp., Santa Clara CA, US |
| Decision | Substantially Equivalent, Aug 31, 2004 |
| Received | Aug 5, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042218
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.