FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER— 510(k) K895506

Name: FDA 510(k) clearance K895506
Creator: U.S. Food and Drug Administration
Published: 1990-02-09

Substantially Equivalent

Vas-Cath, Inc.

FDA 510(k) clearance K895506 for FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER, Substantially Equivalent on 1990-02-09. Applicant: Vas-Cath, Inc.. Device class: 2.

Clearance details

Applicant: Vas-Cath, Inc.
Product code: Code LFJ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1989-09-12
Decision date: 1990-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.