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

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.

Clearance details

Applicant: Peripheral Systems Group
Product code: Code KOE
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

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