Cleared Traditional

ARTERIA OCCLUSION BALLOON

K021210 · Arteria Medical Science, Inc. · Cardiovascular

Oct 2002

Decision

194d

Days

Class 2

Risk

About This 510(k) Submission

K021210 is an FDA 510(k) clearance for the ARTERIA OCCLUSION BALLOON, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Arteria Medical Science, Inc. (Newburyport, US). The FDA issued a Cleared decision on October 28, 2002, 194 days after receiving the submission on April 17, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K021210 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2002
Decision Date	October 28, 2002
Days to Decision	194 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF