HEMASITE VASCULAR ACCESS SHUNT HM-1000— 510(k) K813237

Name: FDA 510(k) clearance K813237
Creator: U.S. Food and Drug Administration
Published: 1981-11-30

Substantially Equivalent

Renal Systems, Inc.

FDA 510(k) clearance K813237 for HEMASITE VASCULAR ACCESS SHUNT HM-1000, Substantially Equivalent on 1981-11-30. 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: 1981-11-10
Decision date: 1981-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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