POWERCROSS .018 OTW PTA DILATION CATHETER
FDA 510(k) clearance K093286 · decided 2009-11-13
Clearance details
- K-number
- K093286
- Device name
- POWERCROSS .018 OTW PTA DILATION CATHETER
- Applicant
- Ev3, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-20
- Decision date
- 2009-11-13
- Days to decision
- 24 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 |
|---|---|---|
| ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA recall (Z-0892-2017) | Medtronic Inc | 2016-12-22 |
| ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx recall (Z-1552-2016) | ev3, Inc. | 2016-04-22 |