510(k) K071309 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
BLUE MAX BALLOON DILATATION CATHETER
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Jul 13, 2007 |
| Received | May 9, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071309
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2010 | Boston Scientific Corporation Boston Scientific BLUE MAX" 20 Balloon Dilatation Catheter, UPN M001125420 (BMQ/7-4/5.8/40, 12-542), M001125630(BMQ/9-8/5.8/40, 12-563) Made in Ireland, Ballybrit Business Park, Galway, Ireland
Recom Terminated |
LIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.