Cleared Special

HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER

K993581 · Haemonetics Corp. · Anesthesiology

Nov 1999

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K993581 is an FDA 510(k) clearance for the HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on November 18, 1999, 27 days after receiving the submission on October 22, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number	K993581 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 22, 1999
Decision Date	November 18, 1999
Days to Decision	27 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF