510(k) K012537 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
REPROCESSED IMAGING CATHETERS
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Oct 11, 2002 |
| Received | Aug 7, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012537
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.