Cleared Traditional

K914119 - DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM (FDA 510(k) Clearance)

K914119 · Davol, Inc. · Anesthesiology device

Dec 1992

Decision

447d

Days

Class 2

Risk

K914119 is an FDA 510(k) clearance for the DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).

Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on December 3, 1992, 447 days after receiving the submission on September 13, 1991.

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

Submission Details

510(k) Number	K914119 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 13, 1991
Decision Date	December 03, 1992
Days to Decision	447 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF