BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX
FDA 510(k) clearance K032292 · decided 2004-03-22
Clearance details
- K-number
- K032292
- Device name
- BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX
- Applicant
- Bioteque Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-24
- Decision date
- 2004-03-22
- Days to decision
- 242 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Flagstaff, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.