RAPIDO CUT-AWAY CUTTER
FDA 510(k) clearance K031459 · decided 2003-07-23
Clearance details
- K-number
- K031459
- Device name
- RAPIDO CUT-AWAY CUTTER
- Applicant
- Guidant Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-08
- Decision date
- 2003-07-23
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Guidant RAPIDO Cut-Away Guiding Catheter, 6F. Part Numbers: 66676-201 and 667552-100. For recall (Z-2793-2011) | Abbott Vascular | 2011-07-12 |