Carbomedics, Inc. - FDA 510(k) Cleared Devices

Cleared Jul 25, 1997

ANNULOFLO SYSTEM

K970375 · KRH

Cardiovascular · 172d

Cleared Feb 19, 1997

VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)

K964665 · DSY

Cardiovascular · 90d

Cleared Aug 27, 1996

CARBOMEDICS HANDLE

K962154 · DTJ

Cardiovascular · 84d

Cleared Apr 29, 1996

CARBOMEDICS MITRAL ROTATOR

K960923 · MOP

Cardiovascular · 54d

Cleared Apr 25, 1996

VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT

K960706 · DSY

Cardiovascular · 64d

Cleared Apr 15, 1996

CARBOMEDICS VALVE TESTER

K960169 · DTJ

Cardiovascular · 90d

Cleared Mar 07, 1996

VASCUTEK GRAFT SIZER SET

K955588 · DSY

Cardiovascular · 91d

Cleared Nov 29, 1995

CARBOMEDICS SUPRA-ANNULAR VALVE SIZER

K952184 · DTI

Cardiovascular · 204d

Cleared Jun 20, 1995

CARBOMEDICS EXENDED MITRAL ROTATOR

K951368 · MOP

Cardiovascular · 85d

Cleared Jul 06, 1994

CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE

K942736 · DTJ

Cardiovascular · 26d

Cleared Dec 10, 1993

VALVE SIZER

K934951 · DTI

Cardiovascular · 53d

Cleared Feb 10, 1984

MINATURE PRESSURE TRANSDUCER

K834040 · DXO

Cardiovascular · 79d