APEX(TM) PROSTATIC BALLOON DILATION CATHETER— 510(k) K913477

Name: FDA 510(k) clearance K913477
Creator: U.S. Food and Drug Administration
Published: 1991-12-27

Substantially Equivalent

Peripheral Systems Group

FDA 510(k) clearance K913477 for APEX(TM) PROSTATIC BALLOON DILATION CATHETER, Substantially Equivalent on 1991-12-27. Applicant: Peripheral Systems Group. Device class: 2.

Clearance details

Applicant: Peripheral Systems Group
Product code: Code KOE
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1991-08-05
Decision date: 1991-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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