Product Code: DWA FDA class 2 21 CFR 870.4380

Control, Pump Speed, Cardiopulmonary Bypass

Cardiovascular

The Cardiopulmonary Bypass Pump Speed Control is a life-sustaining cardiovascular device used to regulate the rotational speed of blood pumps within the extracorporeal circuit, controlling the flow rate of blood delivered to the patient during open-heart surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWA and it is regulated under 21 CFR 870.4380 within the Cardiovascular medical specialty. This device is designated as life-sustaining or life-supporting.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: DWA
Device Class: FDA class 2
Regulation Number: 870.4380
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 37 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K232788	INSPIRA ART100	May 24, 2024	Substantially Equivalent	Inspira Technologies Oxy B.H.N. , Ltd.
K230698	Anivia SG1000 Pump Console	Apr 18, 2023	Substantially Equivalent	Apmtd, Inc.
K221491	Anivia SG1000 Pump Console	Feb 03, 2023	Substantially Equivalent	Apmtd, Inc.
K192838	Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure	Apr 13, 2020	Substantially Equivalent	Spectrum Medical , Ltd.
K200306	CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit	Mar 06, 2020	Substantially Equivalent	Abbott (Formerly Thoratec Corporation)
K191557	CentriMag Acute Circulatory Support System	Jul 10, 2019	Substantially Equivalent	Thoratec Corporation (Now Part of Abbott)
K131964	BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE	Jul 24, 2013	Substantially Equivalent	Medtronic, Inc.
K131179	CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR	Jul 18, 2013	Substantially Equivalent	Thoratec Corp
K112225	SORIN CENTRIFUGAL PUMP 5 (CP5)	Sep 20, 2011	Substantially Equivalent	Sorin Group Deutschland GmbH
K103468	STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)	Jan 20, 2011	Substantially Equivalent	Sorin Group Deutschland GmbH
K102129	LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR	Aug 27, 2010	Substantially Equivalent	Levitronix, LLC
K093832	LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES	Jan 13, 2010	Substantially Equivalent	Levitronix, LLC
K091008	STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55	Jul 15, 2009	Substantially Equivalent	Sorin Group Deutschland GmbH
K090004	LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES	Jan 15, 2009	Substantially Equivalent	Levitronix, LLC
K083340	LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE	Nov 26, 2008	Substantially Equivalent	Levitronix, LLC
K081221	LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE	Jun 19, 2008	Substantially Equivalent	Levitronix, LLC
K080824	BIO-CONSOLE 560	May 07, 2008	Substantially Equivalent	Medtronic Perfusion Systems
K070286	BIO-CONSOLE, MODEL 560	May 22, 2007	Substantially Equivalent	Medtronic
K061369	TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500	Aug 22, 2006	Substantially Equivalent	Cardiacassist, Inc.
K053630	LEVITRONIX CENTRIMAG PRIMARY CONSOLE	Jan 26, 2006	Substantially Equivalent	Levitronix, LLC
K051303	BIO-CONSOLE, MODEL 560	Jun 10, 2005	Substantially Equivalent	Medtronic Perfusion Systems
K042374	STOCKERT SCP RHYTHM	Sep 23, 2004	Substantially Equivalent	Stockert Instrumente GmbH
K032213	STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP	Aug 29, 2003	Substantially Equivalent	Stockert Instrumente GmbH
K011838	CENTRIFUGAL PUMP	Feb 05, 2002	Substantially Equivalent	Stockert Instrumente GmbH
K971421	BARD ISOFLOW BLOOD PUMP	May 14, 1998	Substantially Equivalent	C.R. Bard, Inc.
K950739	3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM	Nov 17, 1995	Substantially Equivalent	3M Health Care, Sarns
K936091	MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER	Dec 23, 1994	Substantially Equivalent	Medtronic Bio-Medicus, Inc.
K941921	BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550	Jul 20, 1994	Substantially Equivalent	Medtronic Bio-Medicus, Inc.
K926357	MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150	Jun 02, 1993	Substantially Equivalent	Medtronic Bio-Medicus, Inc.
K924206	MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E	May 07, 1993	Substantially Equivalent	Medtronic Bio-Medicus, Inc.
K924205	MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550	May 06, 1993	Substantially Equivalent	Medtronic Bio-Medicus, Inc.
K914754	MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D	May 20, 1992	Substantially Equivalent	Medtronic Bio-Medicus, Inc.
K901584	BIO-MEDICUS BIO CONSOLE MODELS 540 A B C	Jun 28, 1990	Substantially Equivalent	Bio Medicus, Inc.
K854133	BIO MEDICUS BIO CONSOLE 540	Jan 08, 1986	Substantially Equivalent	Bio Medicus, Inc.
K853126	BIO PACK MODEL 200	Oct 11, 1985	Substantially Equivalent	Bio Medicus, Inc.
K842503	GAMBRO PULSATILE MONITOR PLM 10-200	Aug 10, 1984	Substantially Equivalent	Gambro, Inc.
K780952	MODEL 1812 CONTROL CONSOLE, ACCESSORIEX	Aug 31, 1978	Substantially Equivalent	Medtronic Vascular