Cleared Traditional

K041525 - HEMOVAC BLOOD REINFUSION SYSTEM (FDA 510(k) Clearance)

K041525 · Zimmer, Inc. · Anesthesiology device

Oct 2004

Decision

128d

Days

Class 2

Risk

K041525 is an FDA 510(k) clearance for the HEMOVAC BLOOD REINFUSION SYSTEM. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).

Submitted by Zimmer, Inc. (Dover, US). The FDA issued a Cleared decision on October 14, 2004, 128 days after receiving the submission on June 8, 2004.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number	K041525 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 08, 2004
Decision Date	October 14, 2004
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF