Product Code: MJJ FDA class 2 21 CFR 870.4400

Cpb Check Valve, Retrograde Flow, In-Line

Cardiovascular

The Cardiopulmonary Bypass (CPB) In-Line Retrograde Flow Check Valve is a one-directional valve incorporated into cardiopulmonary bypass circuits to prevent retrograde blood flow within the extracorporeal circulation system during open heart surgery. Classified as a Class 2 device under 21 CFR 870.4400 within the Cardiovascular specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: MJJ
Device Class: FDA class 2
Regulation Number: 870.4400
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 9 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K182442	MiniGuard Arterial Safety Valve	Nov 06, 2018	Substantially Equivalent	Quest Medical, Inc.
K142500	One Way Soft Valve	Jan 29, 2015	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K001245	3T L. V. CONTROL VALVE	Aug 15, 2001	Substantially Equivalent	3t Medical Systems, LLC
K992785	IBC FLOGUARD, MODEL 6050	Jan 14, 2000	Substantially Equivalent	International Biophysics Corp.
K982406	COBE VACUUM RELIEF CHECK VALVE	Oct 07, 1998	Substantially Equivalent	Cobe Cardiovascular, Inc.
K960937	SUCTION SAFETY DEVICE	Jun 05, 1996	Substantially Equivalent	R D Intl.
K922781	FLOW CONROL VALVE	Mar 08, 1993	Substantially Equivalent	American Omni Medical, Inc.
K922356	FLOW CONTROL VALVE, CAT. NO. ACV-38	Feb 12, 1993	Substantially Equivalent	American Omni Medical, Inc.
K921500	CENTRI-SAFE(TM) VALVE	Sep 15, 1992	Substantially Equivalent	Cardio Systems, Inc.