FC-101 FEMORAL CATHETER GUIDE WIRE— 510(k) K891764

Name: FDA 510(k) clearance K891764
Creator: U.S. Food and Drug Administration
Published: 1989-04-07

Substantially Equivalent

Akcess Medical Products, Inc.

FDA 510(k) clearance K891764 for FC-101 FEMORAL CATHETER GUIDE WIRE, Substantially Equivalent on 1989-04-07. Applicant: Akcess Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Akcess Medical Products, Inc.
Product code: Code LFK
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1989-03-24
Decision date: 1989-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

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K891763 — FC-100 FEMORAL CATHETER1989-04-07
K890717 — MODIFICATION HEMOFILTRATION CATHETER HF-1001989-04-05

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