NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA
FDA 510(k) clearance K991623 · decided 1999-08-09
Clearance details
- K-number
- K991623
- Device name
- NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA
- Applicant
- Nipro Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-11
- Decision date
- 1999-08-09
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FIE
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lexington, KY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.