Cleared Traditional

K881350 - CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM (FDA 510(k) Clearance)

K881350 · Stryker Corp. · Anesthesiology device

Sep 1988

Decision

184d

Days

Class 2

Risk

K881350 is an FDA 510(k) clearance for the CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on September 30, 1988, 184 days after receiving the submission on March 30, 1988.

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

Submission Details

510(k) Number	K881350 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 30, 1988
Decision Date	September 30, 1988
Days to Decision	184 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—