Cleared Traditional

CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM

K883934 · Haemonetics Corp. · Anesthesiology
Dec 1988
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K883934 is an FDA 510(k) clearance for the CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on December 27, 1988, 103 days after receiving the submission on September 15, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K883934 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1988
Decision Date December 27, 1988
Days to Decision 103 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAC — Apparatus, Autotransfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5830

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