Medical Device Manufacturer · US , Mchenry , IL

Kontron Instruments, Inc. - FDA 510(k) Cleared Devices

57 submissions · 57 cleared · Since 1981

57

Total

57

Cleared

0

Denied

FDA 510(k) Regulatory Record - Kontron Instruments, Inc. Cardiovascular ✕

37 devices

1-12 of 37

Cleared Dec 15, 1993

MODIFICATIONS TO INTRA-AORTIC BALLOONS

Cardiovascular · 259d

Cleared Sep 27, 1993

MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS

Cardiovascular · 346d

Cleared Mar 08, 1993

INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION

Cardiovascular · 249d

Cleared Jun 19, 1991

KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II

Cardiovascular · 203d

Cleared Jan 15, 1991

9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)

Cardiovascular · 174d

Cleared Dec 03, 1990

KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM

Cardiovascular · 389d

Cleared Sep 14, 1990

9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON

Cardiovascular · 529d

Cleared Jan 26, 1990

SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283

Cardiovascular · 561d

Cleared Dec 13, 1989

MINIMON 7133B PATIENT MONITOR

Cardiovascular · 37d

Cleared Dec 12, 1989

KONTRON KOLORMON 7250 PATIENT MONITOR

Cardiovascular · 34d

Cleared Sep 20, 1989

10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON

Cardiovascular · 156d

Cleared Sep 20, 1989

9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON

Cardiovascular · 156d

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