Cleared Traditional

K940678 - AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER (FDA 510(k) Clearance)

K940678 · Baxter Healthcare Corp · Anesthesiology device

Apr 1994

Decision

65d

Days

Class 2

Risk

K940678 is an FDA 510(k) clearance for the AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).

Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on April 15, 1994, 65 days after receiving the submission on February 9, 1994.

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

Submission Details

510(k) Number	K940678 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 09, 1994
Decision Date	April 15, 1994
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement