Cleared Traditional

CELL SAVER SUCTION SYSTEM

K852425 · Haemonetics Corp. · Anesthesiology
Sep 1985
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K852425 is an FDA 510(k) clearance for the CELL SAVER SUCTION SYSTEM, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on September 3, 1985, 88 days after receiving the submission on June 7, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K852425 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 1985
Decision Date September 03, 1985
Days to Decision 88 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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