Cleared Traditional

ARTERIA BLOOD FILTER

K021293 · Arteria Medical Science, Inc. · General Hospital

Aug 2002

Decision

121d

Days

Class 2

Risk

About This 510(k) Submission

K021293 is an FDA 510(k) clearance for the ARTERIA BLOOD FILTER, a Filter, Infusion Line (Class II — Special Controls, product code FPB), submitted by Arteria Medical Science, Inc. (Newburyport, US). The FDA issued a Cleared decision on August 22, 2002, 121 days after receiving the submission on April 23, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K021293 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 2002
Decision Date	August 22, 2002
Days to Decision	121 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF