Medical Device Manufacturer · US , Mchenry , IL

Cardiac Pacemakers, Inc.

76 submissions · 76 cleared · Since 1977
76
Total
76
Cleared
0
Denied

Cardiac Pacemakers, Inc. — FDA 510(k) Submissions

Cardiac Pacemakers, Inc. has submitted 76 FDA 510(k) premarket notifications since 1977, of which 76 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Implantable Pacemaker Pulse-generator, Pump, Infusion, Programmer, Pacemaker, Pacemaker Lead Adaptor, Instruments, Surgical, Cardiovascular . Use the specialty filter in the sidebar to narrow results.

76 devices
1–25 of 76
ACUITY BREAK-AWAY GUIDE CATHETER
K093969 · DQY Catheter, Percutaneous · Cardiovascular
Mar 2010 72d
ACUITY UNIVERSAL CUTTER
K080154 · DQY Catheter, Percutaneous · Cardiovascular
Mar 2008 57d
REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER
K934727 · DWS Instruments, Surgical,... · Cardiovascular
Jan 1994 101d
ASTRA T2, ASTRA T4, ASTRA T6
K920601 · DXY Implantable Pacemaker... · Cardiovascular
Oct 1992 260d
PDT CARRYALL TRANSMITTER, VARIOUS MODELS
K912379 · DXH Transmitters And... · Cardiovascular
Jun 1991 19d
LEAD STYLET
K905674 · DRB Stylet, Catheter · Cardiovascular
Jan 1991 43d
MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
K900498 · LZG Pump, Infusion, Insulin · General Hospital
Feb 1990 36d
MODEL 6888 LEAD TUNNELER
K894738 · DWS Instruments, Surgical,... · Cardiovascular
Sep 1989 48d
ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
K890785 · DXY Implantable Pacemaker... · Cardiovascular
Mar 1989 23d
TORQUE HEX WRENCH
K875147 · DTF Tools, Pacemaker Service · Cardiovascular
Jan 1988 43d
BETATRON IV SYSTEM
K872774 · FRN Pump, Infusion · General Hospital
Jan 1988 175d
ASTRA T2, T4 AND T6
K865013 · DXY Implantable Pacemaker... · Cardiovascular
Feb 1987 58d
ULTRA SOFTWARE MODULE: MODEL 2016
K863046 · KRG Programmer, Pacemaker · Cardiovascular
Dec 1986 115d
PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580
K863045 · KRG Programmer, Pacemaker · Cardiovascular
Sep 1986 48d
ASTRA 2,3,4 AND 6: CHIP REVISION
K863000 · Cardiovascular
Aug 1986 11d
ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR
K860585 · DXY Implantable Pacemaker... · Cardiovascular
Jul 1986 148d
SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN
K860584 · KRG Programmer, Pacemaker · Cardiovascular
Jun 1986 108d
TELEMETRY WAND MODEL
K855171 · DXY Implantable Pacemaker... · Cardiovascular
Jan 1986 27d
INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123
K852060 · FRN Pump, Infusion · General Hospital
Jun 1985 29d
ASTRA 2, ASTRA 3, 4 & 6
K842394 · DXY Implantable Pacemaker... · Cardiovascular
Oct 1984 120d
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
K842364 · KRG Programmer, Pacemaker · Cardiovascular
Sep 1984 98d
SENTRA
K843060 · DTD Pacemaker Lead Adaptor · Cardiovascular
Sep 1984 48d
BETATRON I AMBULATORY INSULIN PUMP
K833306 · FRN Pump, Infusion · General Hospital
Nov 1983 66d
COMMAND ULTRA II
K831216 · DXY Implantable Pacemaker... · Cardiovascular
Jul 1983 89d
COMMAND ULTRA I
K831161 · DXY Implantable Pacemaker... · Cardiovascular
Jun 1983 65d

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