Hemovac Autotransfusion System

FDA 510(k) K920273 · Zimmer Patient Care Division

Substantially Equivalent

510(k) numberK920273

Submission

Device name
Hemovac Autotransfusion System
Applicant
Zimmer Patient Care Division
Dover, OH, US
Received
January 22, 1992
Decision date
January 28, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CAC – Apparatus, Autotransfusion
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5830
Specialty
Anesthesiology
Life-sustaining
Yes

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K240584XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special Sorin Group Italia S.R.L.04/29/2024SE
K231782FlowSaver Blood Return System (80-101)CAC · Special Inari Medical, Inc.07/14/2023SE
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K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional Haemonetics Corporation11/15/2022SE
K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional Atrium Medical Corporation09/03/2021SE
K210862Hemafuse SystemCAC · Traditional Sisu Global Health07/29/2021SE
K210176FlowSaver Blood FilterCAC · Traditional Inari Medical07/22/2021SE
K210089CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special Fresenius Kabi AG02/11/2021SE

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Questions and answers

When was Hemovac Autotransfusion System cleared by the FDA?

Hemovac Autotransfusion System (K920273) received a 510(k) decision of Substantially Equivalent on January 28, 1993, 372 days after the submission was received.

What is the product code of K920273?

The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.