CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)— 510(k) K971897

Name: FDA 510(k) clearance K971897
Creator: U.S. Food and Drug Administration
Published: 1997-10-21

Substantially Equivalent

Medron, Inc.

FDA 510(k) clearance K971897 for CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH), Substantially Equivalent on 1997-10-21. Applicant: Medron, Inc.. Device class: 2.

Clearance details

Applicant: Medron, Inc.
Product code: Code LFK
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1997-05-22
Decision date: 1997-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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