.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
FDA 510(k) clearance K111295 · decided 2011-05-31
Clearance details
- K-number
- K111295
- Device name
- .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-05-10
- Decision date
- 2011-05-31
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, recall (Z-1042-2026) | Boston Scientific Corporation | 2026-01-09 |
| Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H749391 recall (Z-0969-2014) | Boston Scientific Corporation | 2014-02-11 |
| Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H7493918520151 recall (Z-0971-2014) | Boston Scientific Corporation | 2014-02-11 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Axonics Sacral Neuromodulation System (P180046/S113) | Boston Scientific Corporation | 2026-08-07 |
| Axonics Sacral Neuromodulation System (P190006/S113) | Boston Scientific Corporation | 2026-08-07 |
| Innova Self Expanding Stent System (P140028/S087) | Boston Scientific Corporation | 2026-08-06 |
| Ranger Paclitaxel-Coated Balloon Catheter (P190019/S043) | Boston Scientific Corporation | 2026-08-04 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S009) | Boston Scientific Corporation | 2026-07-30 |
| Axonics Sacral Neuromodulation System (P180046/S110) | Boston Scientific Corporation | 2026-07-24 |
| Axonics Sacral Neuromodulation System (P190006/S110) | Boston Scientific Corporation | 2026-07-24 |
| S-ICD EMBLEM GEN 2 (A209); S-ICD EMBLEM MRI (A219) (P110042/S215) | Boston Scientific Corporation | 2026-07-23 |