HEMASITE/RENALOY -VASCULAR ACCESS SHUNT— 510(k) K840436

Name: FDA 510(k) clearance K840436
Creator: U.S. Food and Drug Administration
Published: 1984-02-21

Substantially Equivalent

Renal Systems, Inc.

FDA 510(k) clearance K840436 for HEMASITE/RENALOY -VASCULAR ACCESS SHUNT, Substantially Equivalent on 1984-02-21. 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: 1984-02-01
Decision date: 1984-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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