Cleared Traditional

K914053 - SYSTEM 350 (FDA 510(k) Clearance)

K914053 · Stryker Corp. · Anesthesiology device

Sep 1992

Decision

382d

Days

Class 2

Risk

K914053 is an FDA 510(k) clearance for the SYSTEM 350. 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 25, 1992, 382 days after receiving the submission on September 9, 1991.

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

Submission Details

510(k) Number	K914053 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 09, 1991
Decision Date	September 25, 1992
Days to Decision	382 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement