VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO
FDA 510(k) clearance K051062 · decided 2005-07-15
Clearance details
- K-number
- K051062
- Device name
- VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO
- Applicant
- Flowcardia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-26
- Decision date
- 2005-07-15
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.