FLEXIBLE VISUALIZATION CATHETER— 510(k) K862872

Name: FDA 510(k) clearance K862872
Creator: U.S. Food and Drug Administration
Published: 1986-10-24

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K862872 for FLEXIBLE VISUALIZATION CATHETER, Substantially Equivalent on 1986-10-24. Applicant: American Edwards Laboratories. Device class: 1.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code FEI
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1986-07-30
Decision date: 1986-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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