Cleared Special

HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)

K053000 · Haemonetics Corp. · Anesthesiology
Nov 2005
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K053000 is an FDA 510(k) clearance for the HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT), a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on November 21, 2005, 27 days after receiving the submission on October 25, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K053000 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2005
Decision Date November 21, 2005
Days to Decision 27 days
Submission Type Special
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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