FASGUIDE
FDA 510(k) clearance K951159 · decided 1995-09-25
Clearance details
- K-number
- K951159
- Device name
- FASGUIDE
- Applicant
- Target Therapeutics
- Decision
- Substantially Equivalent
- Date received
- 1995-03-14
- Decision date
- 1995-09-25
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Freemont, 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.