VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)— 510(k) K972100

Name: FDA 510(k) clearance K972100
Creator: U.S. Food and Drug Administration
Published: 1997-07-31

Substantially Equivalent

Advanced Care Medical Products

FDA 510(k) clearance K972100 for VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000), Substantially Equivalent on 1997-07-31. Applicant: Advanced Care Medical Products. Device class: 1.

Clearance details

Applicant: Advanced Care Medical Products
Product code: Code EXJ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1997-06-04
Decision date: 1997-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Novato, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXJ

view all

K970465 — BOUSER'S URINAL1997-12-18
K970966 — COMFORT CATH CHOICE MALE EXTERNAL CATHETER1997-04-22
K963265 — PROSYS SAMEC LA1996-10-25
K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETER1996-09-16
K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER1996-07-15

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