510(k) K163174 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Emerge PTCA Dilatation Catheter
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Dec 14, 2016 |
| Received | Nov 14, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163174
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2019 | Boston Scientific Corporation Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm;
2. REF/Catalog No. H749 Terminated |
LOX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.