ARTERIO VENOUS SHUNT CANNULA & ADAPTORS— 510(k) K822880

Name: FDA 510(k) clearance K822880
Creator: U.S. Food and Drug Administration
Published: 1982-10-18

Substantially Equivalent

Renal Systems, Inc.

FDA 510(k) clearance K822880 for ARTERIO VENOUS SHUNT CANNULA & ADAPTORS, Substantially Equivalent on 1982-10-18. Applicant: Renal Systems, Inc.. Device class: 2.

Clearance details

Applicant: Renal Systems, Inc.
Product code: Code FIQ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1982-09-21
Decision date: 1982-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FIQ

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K892887 — ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA1989-05-15
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K892666 — SAF-T-SHUNT, S-300 SERIES1989-05-04
K844692 — PEDIATRIC SIZED HEMOCATH CATHETER1985-01-18
K841791 — PLUME FISTULA NEEDLE1984-07-09

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K861730 — ACTRIL FOR KIDNEY MACHINE DISINFECTANT1987-06-09
K854011 — RENALFO HEMOFILTER CAVHD1985-11-05
K844790 — RENAFLO HEMOCONCENTRATOR1985-05-23
K843963 — DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD1985-01-07

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