510(k) K111295 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, May 31, 2011 |
| Received | May 10, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111295
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2026 | Boston Scientific Corporation Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F,
1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210;
2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210;
Cat Open, Classified |
LIT | None listed |
| Feb 11, 2014 | Boston Scientific Corporation Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121. Terminated |
LIT | None listed |
| Feb 11, 2014 | Boston Scientific Corporation Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151. Terminated |
LIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.