CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES
FDA 510(k) clearance K972762 · decided 1997-10-14
Clearance details
- K-number
- K972762
- Device name
- CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES
- Applicant
- Cardio Metrics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-24
- Decision date
- 1997-10-14
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FloWire Doppler Guide wires. Volcano Corporation, Rancho Cardova, Ca. The Volcano FloWire recall (Z-0935-2012) | Volcano Corporation | 2012-02-01 |