510(k) K110076 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Aug 18, 2011 |
| Received | Jan 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110076
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2014 | STERILMED, INC. Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577. Terminated |
OWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.