Cleared Traditional

AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM

K014187 · Boehringer Laboratories · Anesthesiology
Feb 2002
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K014187 is an FDA 510(k) clearance for the AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on February 6, 2002, 47 days after receiving the submission on December 21, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K014187 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2001
Decision Date February 06, 2002
Days to Decision 47 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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

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