Cleared Traditional

K932228 - MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
(FDA 510(k) Clearance)

K932228 · Boston Scientific Corp · General & Plastic Surgery

Aug 1993

Decision

95d

Days

Class 1

Risk

K932228 is an FDA 510(k) clearance for the MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER, a Catheter, Cholangiography (Class I — General Controls, product code GBZ), submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on August 10, 1993, 95 days after receiving the submission on May 7, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number	K932228 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 07, 1993
Decision Date	August 10, 1993
Days to Decision	95 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF