510(k) K022620 ยท FKA Dilator, Vessel
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
| Applicant | Spire Biomedical, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Oct 11, 2002 |
| Received | Aug 7, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022620
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.