MJJ — Cpb Check Valve, Retrograde Flow, In-Line Class II

FDA Device Classification

FDA product code MJJ covers "Cpb Check Valve, Retrograde Flow, In-Line", a Class II medical device regulated under 21 CFR 870.4400. Submissions are reviewed by the Cardiovascular panel. At least 9 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MJJ
Device Class
Class II
Regulation Number
870.4400
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K182442quest medicalMiniGuard Arterial Safety ValveNovember 6, 2018
K142500terumo cardiovascular systems corporationOne Way Soft ValveJanuary 29, 2015
K0012453t medical systems3T L. V. CONTROL VALVEAugust 15, 2001
K992785international biophysicsIBC FLOGUARD, MODEL 6050January 14, 2000
K982406cobe cardiovascularCOBE VACUUM RELIEF CHECK VALVEOctober 7, 1998
K960937r d intlSUCTION SAFETY DEVICEJune 5, 1996
K922781american omni medicalFLOW CONROL VALVEMarch 8, 1993
K922356american omni medicalFLOW CONTROL VALVE, CAT. NO. ACV-38February 12, 1993
K921500cardio systemsCENTRI-SAFE(TM) VALVESeptember 15, 1992