.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS— 510(k) K111295
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K111295 for .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS, Substantially Equivalent on 2011-05-31. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Maple Grove, MN, US
Recent devices under product code LIT
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K111295
K-number listed on FDA's recall record- Z-1042-2026 — 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; Catheter, Angioplasty, Peripheral, Transluminal
- Z-0969-2014 — Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.
- Z-0971-2014 — Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111295.
Data sourced from openFDA. This site is unofficial and independent of the FDA.