Cleared Traditional

HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM

K043127 · Haemonetics Corp. · Anesthesiology
Jan 2005
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K043127 is an FDA 510(k) clearance for the HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on January 4, 2005, 53 days after receiving the submission on November 12, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K043127 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2004
Decision Date January 04, 2005
Days to Decision 53 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

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

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