Medical Device Manufacturer · US , Mchenry , IL

Cardio Systems, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1979

Total

Cleared

Denied

Cardio Systems, Inc. has 9 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 9 cleared submissions from 1979 to 2013. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Cardio Systems, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Cardio Systems, Inc.

9 devices

1-9 of 9

Cleared Jun 24, 2013

STEALTH 360 ORBITAL PAD SYSTEM

K131092 · MCW

Cardiovascular · 67d

Cleared Aug 14, 2008

MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM

General Hospital · 234d

Cleared Feb 02, 1994

LOW AIR LOSS MATTRESS, MODIFICATION

K934689 · INX

Physical Medicine · 163d

Cleared Sep 15, 1992

CENTRI-SAFE(TM) VALVE

K921500 · MJJ

Cardiovascular · 168d

Cleared Dec 01, 1988

ADD-ON TO CRITICAL PATIENT CARE BED

K882177 · IOQ

Physical Medicine · 191d

Cleared Sep 18, 1985

BAYLOR RAPID AUTOTRANSFUSION SYSTEM

K852736 · CAC

Anesthesiology · 133d

Cleared Nov 13, 1979

OXYGENATOR GAS LINE FILTER

K792151 · KRI

Cardiovascular · 22d

Cleared Nov 13, 1979

CARDIOPLEGIA SOLUTION ADMIN. SET

K792152 · DWF

Cardiovascular · 22d

Cardio Systems, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Cardio Systems, Inc.

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