MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150
FDA 510(k) clearance K090849 · decided 2009-05-01
Clearance details
- K-number
- K090849
- Device name
- MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150
- Applicant
- Ev3, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-30
- Decision date
- 2009-05-01
- Days to decision
- 32 days
- Clearance type
- Special
- Product code
- DQY
- 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 |
|---|---|---|
| ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF # recall (Z-0789-2011) | Ev3, Inc. | 2010-12-23 |