Medical Device Manufacturer · US , Mchenry , IL

Cook Pacemaker Corp. - FDA 510(k) Cleared Devices

34 submissions · 31 cleared · Since 1981

Recent clearances: LOCKING STYLET 2, NEEDLE'S EYE SNARE, MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS

34

Total

31

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cook Pacemaker Corp. Cardiovascular ✕

34 devices

1-12 of 34

Cleared May 20, 1997

LOCKING STYLET 2

Cardiovascular · 84d

Cleared Dec 27, 1996

NEEDLE'S EYE SNARE

Cardiovascular · 220d

Cleared Sep 29, 1995

MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS

Cardiovascular · 113d

Cleared Sep 11, 1992

MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD

Cardiovascular · 298d

Cleared Oct 16, 1991

MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER

Cardiovascular · 317d

Cleared Oct 08, 1986

MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)

Cardiovascular · 23d

Cleared May 09, 1986

SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS

Cardiovascular · 14d

Cleared Feb 24, 1986

MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.

Cardiovascular · 33d

Cleared Feb 24, 1986

MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.

Cardiovascular · 18d

Cleared Dec 19, 1985

BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY

Cardiovascular · 10d

Cleared Dec 03, 1985

COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS

Cardiovascular · 54d

Cleared Oct 23, 1985

COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI

Cardiovascular · 56d