510(k) K141236 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Aug 7, 2014 |
| Received | May 13, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141236
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2019 | Boston Scientific Corporation NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes:
1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM;
2. REF/Catalog No Terminated |
LOX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.