Cleared Traditional

SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14

K024097 · Summit Medical , Ltd. · Anesthesiology
Feb 2003
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K024097 is an FDA 510(k) clearance for the SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Summit Medical , Ltd. (Stevenage Hertfordshire, GB). The FDA issued a Cleared decision on February 14, 2003, 64 days after receiving the submission on December 12, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K024097 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2002
Decision Date February 14, 2003
Days to Decision 64 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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