Fresenius C.A.T.S; Ati Autotransfusion Set; PSQ Plasma Sequestration Set; Psq-Dd Plasma Sequestration Direct Draw

Q: What is the product code of K012178?

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

FDA 510(k) K012178 · Fresenius Hemotechnology, Inc.

Substantially Equivalent

510(k) numberK012178

Submission

Device name: Fresenius C.A.T.S; Ati Autotransfusion Set; PSQ Plasma Sequestration Set; Psq-Dd Plasma Sequestration Direct Draw
Applicant: Fresenius Hemotechnology, Inc.
Redmond, WA, US
Received: July 12, 2001
Decision date: July 23, 2001
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary 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

Other 510(k)s with product code CAC

510(k)	Device	Applicant	Decision
K241236	XTRA Collection sets; XTRA Sequestration set XCAC · Special	Sorin Group Italia S.R.L.	08/16/2024SE
K240426	Aventus Clot Management SystemCAC · Traditional	Inquis Medical	05/14/2024SE
K240584	XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special	Sorin Group Italia S.R.L.	04/29/2024SE
K231782	FlowSaver Blood Return System (80-101)CAC · Special	Inari Medical, Inc.	07/14/2023SE
K221483	FlowSaver Blood Return SystemCAC · Traditional	Inari Medical, Inc.	02/17/2023SE
K221722	Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional	Haemonetics Corporation	11/15/2022SE
K201305	Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional	Atrium Medical Corporation	09/03/2021SE
K210862	Hemafuse SystemCAC · Traditional	Sisu Global Health	07/29/2021SE
K210176	FlowSaver Blood FilterCAC · Traditional	Inari Medical	07/22/2021SE
K210089	CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special	Fresenius Kabi AG	02/11/2021SE

More from Fresenius Kabi AG

510(k)	Device	Decision
K984586	Fresenius ATR40 and ATR120 Autotransfusion ReservoirsDTN · Traditional	06/29/1999SE
K984233	C.A.T.S Autotransfusion Accessories, Models Ats Suction Line, Aty Y-Adapter, and Ato…CAC · Traditional	02/01/1999SE

Questions and answers

When was Fresenius C.A.T.S; Ati Autotransfusion Set; PSQ Plasma Sequestration Set; Psq-Dd Plasma Sequestration Direct Draw cleared by the FDA?

Fresenius C.A.T.S; Ati Autotransfusion Set; PSQ Plasma Sequestration Set; Psq-Dd Plasma Sequestration Direct Draw (K012178) received a 510(k) decision of Substantially Equivalent on July 23, 2001, 11 days after the submission was received.

What is the product code of K012178?

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