Cleared Traditional

K970714 - STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) (FDA 510(k) Clearance)

K970714 · Stryker Instruments · Anesthesiology device

Dec 1997

Decision

292d

Days

Class 2

Risk

K970714 is an FDA 510(k) clearance for the STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII). This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on December 16, 1997, 292 days after receiving the submission on February 27, 1997.

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

Submission Details

510(k) Number	K970714 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 27, 1997
Decision Date	December 16, 1997
Days to Decision	292 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF