RADIUS COUGAR WIRE
FDA 510(k) clearance K032899 · decided 2003-10-17
Clearance details
- K-number
- K032899
- Device name
- RADIUS COUGAR WIRE
- Applicant
- Radius Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-17
- Decision date
- 2003-10-17
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hopkonton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cougar Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, recall (Z-0261-2014) | Medtronic Vascular | 2013-11-15 |
| COUGAR Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic g recall (Z-0266-2014) | Medtronic Vascular | 2013-11-15 |