Medical Device Manufacturer · US , Mchenry , IL

Cardiac Pacemakers, Inc. - FDA 510(k) Cleared Devices

76 submissions · 76 cleared · Since 1977

Recent clearances: ACUITY BREAK-AWAY GUIDE CATHETER, ACUITY UNIVERSAL CUTTER, REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER

76

Total

76

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardiac Pacemakers, Inc. General Hospital ✕

12 devices

1-12 of 12

Cleared Feb 23, 1990

MODIFIED BETATRON IV INSULIN INFUSION SYSTEM

General Hospital · 36d

Cleared Jan 05, 1988

BETATRON IV SYSTEM

General Hospital · 175d

Cleared Jun 07, 1985

INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123

General Hospital · 29d

Cleared Nov 28, 1983

BETATRON I AMBULATORY INSULIN PUMP

General Hospital · 66d

Cleared May 09, 1983

RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE

General Hospital · 21d

Cleared Nov 30, 1982

General Hospital · 34d

Cleared Nov 03, 1982

General Hospital · 50d

Cleared Nov 03, 1982

INFUS. SETS-9120-50 CM & 9121-100 CM,EXT

General Hospital · 50d

Cleared Nov 03, 1982

General Hospital · 50d

Cleared Jan 25, 1982

OPEN LOOP AMBULATORY INSULIN INFUSION

General Hospital · 13d

Cleared Nov 06, 1981

PORTABLE LIDOCAINE INFUSION PUMP

General Hospital · 18d

Cleared Jul 10, 1981

OPEN LOOP AMBULATORY INFUSION DEVICE

General Hospital · 17d