Medical Device Manufacturer · US , Mchenry , IL

American Bentley - FDA 510(k) Cleared Devices

59 submissions · 59 cleared · Since 1983

59

Total

59

Cleared

0

Denied

FDA 510(k) Regulatory Record - American Bentley Cardiovascular ✕

50 devices

1-12 of 50

Cleared Nov 06, 1987

INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER

Cardiovascular · 42d

Cleared Sep 01, 1987

CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100

Cardiovascular · 186d

Cleared Sep 01, 1987

CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500

Cardiovascular · 85d

Cleared Aug 24, 1987

OXYGENATOR MODEL NO. BENTLEY 5 PLUS

Cardiovascular · 83d

Cleared Oct 20, 1986

OXYGENATOR MODEL NO. BENTLEY-10 PLUS

Cardiovascular · 59d

Cleared Sep 29, 1986

HEPARIN-COATED EXTRACORPOREAL CIRCUITS

Cardiovascular · 152d

Cleared Jul 15, 1986

ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE

Cardiovascular · 12d

Cleared Jun 26, 1986

OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B

Cardiovascular · 122d

Cleared Mar 03, 1986

ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL

Cardiovascular · 7d

Cleared Jan 08, 1986

CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH

Cardiovascular · 92d

Cleared Dec 16, 1985

MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED

Cardiovascular · 75d

Cleared Dec 11, 1985

ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL

Cardiovascular · 77d

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