Cleared Traditional

K963850 - PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
(FDA 510(k) Clearance)

K963850 · Deknatel, Inc. · Anesthesiology

Apr 1997

Decision

209d

Days

Class 2

Risk

K963850 is an FDA 510(k) clearance for the PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM. This device is classified as a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC).

Submitted by Deknatel, Inc. (Fall River, US). The FDA issued a Cleared decision on April 22, 1997, 209 days after receiving the submission on September 25, 1996.

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

Submission Details

510(k) Number	K963850 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 1996
Decision Date	April 22, 1997
Days to Decision	209 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF