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K Number
K014187
Device Name
AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
Manufacturer
BOEHRINGER LABORATORIES
Date Cleared
2002-02-06

(47 days)

Product Code
CAC
Regulation Number
868.5830
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Autovac TC system is indicated for the continuous collection and infusion of wound drainage from orthopedic procedures such as Total Knee Replacement, Total Hip Replacement and Spinal Fusion. The blood is to be collected via a surgical drain tube placed in the operative site.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the Autovac Orthopedic Autotransfusion System. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the substantial equivalence determination for marketing the device. Therefore, I cannot extract the requested information from this document.

§ 868.5830 Autotransfusion apparatus.

(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).