Cleared Traditional

K031554 - S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
(FDA 510(k) Clearance)

K031554 · Genzyme Biosurgery · Anesthesiology

Jul 2003

Decision

67d

Days

Class 2

Risk

K031554 is an FDA 510(k) clearance for the S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM. This device is classified as a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC).

Submitted by Genzyme Biosurgery (Fall River, US). The FDA issued a Cleared decision on July 25, 2003, 67 days after receiving the submission on May 19, 2003.

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

Submission Details

510(k) Number	K031554 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 2003
Decision Date	July 25, 2003
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF