Medical Device Manufacturer · US , Walker , MI

Quest Medical, Inc. - FDA 510(k) Cleared Devices

39 submissions · 39 cleared · Since 1980

Recent clearances: Lyka® PORT Needle Free Access Device (4170Y), Q2 Blood Administration Sets, Q2 IV Administration Sets

39

Total

39

Cleared

0

Denied

FDA 510(k) Regulatory Record - Quest Medical, Inc. Cardiovascular ✕

16 devices

1-12 of 16

Cleared Nov 20, 2020

MPS 3 ND Myocardial Protection System

Cardiovascular · 126d

Cleared Jun 19, 2020

MPS 3 Myocardial Protection System

Cardiovascular · 116d

Cleared Nov 06, 2018

MiniGuard Arterial Safety Valve

Cardiovascular · 60d

Cleared Oct 01, 2018

MPS2 Myocardial Protection System Console

Cardiovascular · 300d

Cleared Sep 02, 2004

MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260

Cardiovascular · 41d

Cleared Sep 18, 2000

QUEST MPS BACK-UP SYSYEM

Cardiovascular · 53d

Cleared Nov 06, 1997

QUEST VESSEL CATHETER

Cardiovascular · 163d

Cleared Mar 26, 1996

FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER

Cardiovascular · 91d

Cleared Mar 06, 1996

MYOCARDIAL PROTECTION SYSTEM

Cardiovascular · 203d

Cleared Aug 24, 1995

QUEST VEIN GRAFT PERFUSION SET

Cardiovascular · 84d

Cleared Jun 14, 1995

QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS

Cardiovascular · 97d

Cleared May 25, 1995

QUEST ANTEGRADE CARDIOPLEGIA CANNULA

Cardiovascular · 92d