Cleared Traditional

K012983 - ACIST 4 FRENCH ANGIOGRAPHIC CATHETER (FDA 510(k) Clearance)

K012983 · Acist Medical Systems, Inc. · Cardiovascular device

Mar 2002

Decision

189d

Days

Class 2

Risk

K012983 is an FDA 510(k) clearance for the ACIST 4 FRENCH ANGIOGRAPHIC CATHETER. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).

Submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on March 13, 2002, 189 days after receiving the submission on September 5, 2001.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K012983 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 05, 2001
Decision Date	March 13, 2002
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF