FINDRWIRZ GUIDE WIRE SYSTEM
FDA 510(k) clearance K080364 · decided 2008-08-11
Clearance details
- K-number
- K080364
- Device name
- FINDRWIRZ GUIDE WIRE SYSTEM
- Applicant
- Sentreheart, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-02-11
- Decision date
- 2008-08-11
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in th recall (Z-0328-2017) | SentreHeart Inc | 2016-11-09 |