Cleared Traditional

DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM

K914119 · Davol, Inc. · Anesthesiology
Dec 1992
Decision
447d
Days
Class 2
Risk

About This 510(k) Submission

K914119 is an FDA 510(k) clearance for the DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on December 3, 1992, 447 days after receiving the submission on September 13, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K914119 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1991
Decision Date December 03, 1992
Days to Decision 447 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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