NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
FDA 510(k) clearance K141118 · decided 2014-07-18
Clearance details
- K-number
- K141118
- Device name
- NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
- Applicant
- Ev3, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-04-30
- Decision date
- 2014-07-18
- Days to decision
- 79 days
- Clearance type
- Special
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5M recall (Z-0904-2025) | ev3 Inc | 2025-01-15 |