EVERCROSS 0.035 OTW PTA DILATION CATHETER
FDA 510(k) clearance K103322 · decided 2010-12-06
Clearance details
- K-number
- K103322
- Device name
- EVERCROSS 0.035 OTW PTA DILATION CATHETER
- Applicant
- Ev3, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-12
- Decision date
- 2010-12-06
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. recall (Z-1489-2014) | Ev3, Inc. | 2014-04-23 |