Product Code: DWE FDA class 2 21 CFR 870.4390

Tubing, Pump, Cardiopulmonary Bypass

Cardiovascular

The Cardiopulmonary Bypass Pump Tubing is a cardiovascular disposable device consisting of flexible tubing used within roller pumps or peristaltic pump systems of an extracorporeal circuit to convey blood 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 DWE and it is regulated under 21 CFR 870.4390 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DWE in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: DWE
Device Class: FDA class 2
Regulation Number: 870.4390
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 21 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K233702	SMARxT Tubing and Connectors	Aug 08, 2024	Substantially Equivalent	LivaNova USA, Inc.
K150542	Terumo Pump Tubing	May 01, 2015	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K142607	AngioVac Circuit	Dec 11, 2014	Substantially Equivalent	Angiodynamics
K092486	VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT	Aug 28, 2009	Substantially Equivalent	Vortex Medical, Inc.
K080592	HLM TUBING SET WITH BIOLINE COATING	Sep 11, 2008	Substantially Equivalent	Maquet Cardiopulmonary, AG
K053025	JOSTRA HLM TUBING SET	Nov 10, 2005	Substantially Equivalent	Maquet Cardiopulmonary, AG
K022857	PUMP TUBING WITH X-COATING	Sep 19, 2002	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K013578	PUMP TUBING	Jan 22, 2002	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K993189	CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING	Mar 01, 2000	Substantially Equivalent	Terumo Corp.
K993062	CHEST DRAINAGE TUBING	Dec 10, 1999	Substantially Equivalent	Olson Medical Sales, Inc.
K981613	COBE SMARXT TUBING AND CONNECTORS	Oct 26, 1998	Substantially Equivalent	Cobe Cardiovascular, Inc.
K923231	CARDIO-PAK BASIC PUMP PACK	Jul 09, 1993	Unknown	Cardio-Med-Associates, Inc.
K905686	SARNS TEMPERATURE PROBE AND CONNECTOR	Feb 25, 1991	Substantially Equivalent	3M Health Care, Sarns
K902845	GENTLE HEADER	Dec 03, 1990	Substantially Equivalent	Enhanced Perfusion Systems, Inc.
K894721	TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE	Oct 20, 1989	Substantially Equivalent	The Traumafuse Co.
K841959	CARDIO METRIC CUSTOM PERFUSION TUBING	Oct 19, 1984	Substantially Equivalent	Sterile Design, Inc.
K842044	SARNS EVACUPLEGE CATHETER	Aug 10, 1984	Substantially Equivalent	3M Health Care, Sarns
K810924	MEDRAD HIGH PRESSURE CONECTING TUBE	Apr 17, 1981	Substantially Equivalent	Medrad, Inc.
K803277	TYGON TUBING	Jan 13, 1981	Substantially Equivalent	Electromedics, Inc.
K801394	CARDIOPULMONARY BYPASS PUMP TUBING	Jun 30, 1980	Substantially Equivalent	Texas Medical Products, Inc.
K800178	EXTRACORP.'S INTERSEPT CUS. TUBING PK.	Feb 21, 1980	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.