FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
DST
Clip, Vena-Cava
2
Product Code
DSW
Bag, Polymeric Mesh, Pacemaker
1
Product Code
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
2
Product Code
DSZ
Pacemaker Battery
3
Product Code
DTA
Tester, Pacemaker Electrode Function
2
Product Code
DTB
Permanent Pacemaker Electrode
3
Product Code
DTC
Analyzer, Pacemaker Generator Function
2
Product Code
DTD
Pacemaker Lead Adaptor
2
Product Code
DTE
Pulse-Generator, Pacemaker, External
2
Product Code
DTF
Tools, Pacemaker Service
1
Product Code
DTG
Magnet, Test, Pacemaker
1
Product Code
DTI
Sizer, Heart-Valve, Prosthesis
1
Product Code
DTJ
Holder, Heart-Valve, Prosthesis
1
Product Code
DTK
Filter, Intravascular, Cardiovascular
2
Product Code
DSP
System, Balloon, Intra-Aortic And Control
2
Product Code
DSR
Stimulator, Carotid Sinus Nerve
3
Product Code
DSS
Clip, Vascular
2
Product Code
DXY
Implantable Pacemaker Pulse-Generator
3
Product Code
DXZ
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
2
Product Code
DYE
Replacement Heart-Valve
3
Product Code
DYF
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
2
Product Code
KFJ
Materials, Repair Or Replacement, Pacemaker
3
Product Code
KRD
Device, Vascular, For Promoting Embolization
2
Product Code
KRE
Analyzer, Pacemaker Generator Function, Indirect
2
Product Code
KRF
Charger, Pacemaker
1
Product Code
KRG
Programmer, Pacemaker
3
Product Code
K
93
3278
INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04
3
Cleared 510(K)
K
88
4522
MODEL 5650 OPTIMATE PERSONAL PROGRAMMER
3
Cleared 510(K)
K
88
0738
MODEL 2331T PATIENT PROGRAMMER
3
Cleared 510(K)
K
88
2429
MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004
3
Cleared 510(K)
K
86
4712
MODEL 1740 PERSONAL POCKET PROGRAMMER
3
Cleared 510(K)
K
87
1986
MODEL 5600B PROGRAMMER, PACEMAKER
3
Cleared 510(K)
K
86
3046
ULTRA SOFTWARE MODULE: MODEL 2016
3
Cleared 510(K)
K
86
3045
PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580
3
Cleared 510(K)
K
86
0584
SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN
3
Cleared 510(K)
K
86
0546
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37
3
Cleared 510(K)
P
01
0031
BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D
3
PMA Approval
P
01
0031
APPLICATION SOFTWARE, BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC
3
PMA Approval
P
01
0031
BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE
3
PMA Approval
P
89
0003
MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS
3
PMA Approval
P
88
0086
VICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 5610
3
PMA Approval
P
88
0086
AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
3
PMA Approval
P
83
0045
EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND THE MODEL 3307 V 4.6M SOFTWARE
3
PMA Approval
P
83
0045
VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR
3
PMA Approval
P
83
0045
MODEL 3510 PROGRAMMER AND MODEL 3134 EXTERNAL VIDEO CABLE
3
PMA Approval
P
83
0045
ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND MODEL 3307 V.4.5A SOFTWARE
3
PMA Approval
P
83
0045
ADX PULSE GENERATOR
3
PMA Approval
P
83
0045
IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC
3
PMA Approval
P
83
0045
EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
3
PMA Approval
P
83
0045
IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A
3
PMA Approval
P
83
0045
APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)
3
PMA Approval
P
90
0070
APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)
3
PMA Approval
P
88
0086
AV PLUS DX, MODEL 1368
3
PMA Approval
P
83
0045
MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE
3
PMA Approval
P
83
0045
ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND B-235)
3
PMA Approval
P
83
0045
ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
3
PMA Approval
P
83
0045
IDENTITY PULSE GENERATOR MODEL DR 5370
3
PMA Approval
P
88
0006
REGENCY SC+ PULSE GENERATORS
3
PMA Approval
P
83
0045
INTEGRITY AFX DR MODEL 5346
3
PMA Approval
P
83
0045
MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE
3
PMA Approval
P
83
0045
INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE
3
PMA Approval
P
83
0045
VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE
3
PMA Approval
P
83
0045
INTEGRITY DR MODEL 5336/INTEGRITY SR MODEL 5136
3
PMA Approval
P
83
0045
VENTRITEX ICD'S
3
PMA Approval
P
83
0045
INTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL
3
PMA Approval
P
83
0045
V1. 2A PROGRAMMER SOFTWARE
3
PMA Approval
P
90
0070
TRILOGY/SOLUS II/PARAGON III/PHOENIX III
3
PMA Approval
P
88
0006
V.1 2A PROGRAMMER SOFTWARE
3
PMA Approval
P
88
0006
MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS
3
PMA Approval
P
83
0045
MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS
3
PMA Approval
P
88
0006
MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER
3
PMA Approval
P
83
0045
MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER
3
PMA Approval
P
90
0070
TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ ADDVENT TEMPO
3
PMA Approval
P
83
0045
TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO
3
PMA Approval
P
83
0045
3500/3510 PROGRAMMER
3
PMA Approval
P
83
0045
CARDIAC PACEMAKER PROGRAMMER & BASE STATION
3
PMA Approval
P
88
0086
3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03
3
PMA Approval
P
83
0045
3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03
3
PMA Approval
P
88
0086
AFFINITY SR/DR
3
PMA Approval
P
88
0086
AFFINITY DR & DC; ENTITY DR & DC
3
PMA Approval
P
83
0045
MODEL 3510 PROGRAMMER/3303 SOFTWARE
3
PMA Approval
P
88
0086
MODEL 3510 PROGRAMMER/ 3303 SOFTWARE
3
PMA Approval
P
91
0077
MODEL 2901 PROGRAMMER
3
PMA Approval
P
94
0031
MODEL 2901 PROGRAMMERR SYSTEM
3
PMA Approval
K
84
4484
HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA
3
Cleared 510(K)
K
84
4483
TP 1
3
Cleared 510(K)
K
84
4485
CERYX6, 611, CERYX 3 311 & CERYX 1 111
3
Cleared 510(K)
K
84
2364
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
3
Cleared 510(K)
K
82
0230
PACEMAKER PROGRAMMER 2030
3
Cleared 510(K)
K
81
2761
FLOW-DIRECTED BALLOON THERMODILUTION
3
Cleared 510(K)
K
81
2813
INTERMEDICS PROGRAMMER, MODEL 522-03
3
Cleared 510(K)
K
81
1217
PACEMAKER PROGRAMMER #2010
3
Cleared 510(K)
K
81
0552
CORDIS PACEMAKER PROGRAMMERS 255A & 256A
3
Cleared 510(K)
K
80
0376
EPR-200 PROGRAMMER MODEL 010
3
Cleared 510(K)
K
79
2580
PACEMAKER PROGRAMMER
3
Cleared 510(K)
K
79
1419
OMNICOR PROGRAMMER MODEL 222C
3
Cleared 510(K)
K
79
0220
PACEMAKER PROGRAMMER
3
Cleared 510(K)
K
78
0175
RATE PROGRAMMER MODEL 520
3
Cleared 510(K)
K
77
1855
OMNICOR PROGRAMMER MODEL 222A
3
Cleared 510(K)
KRH
Ring, Annuloplasty
2
Product Code
LDF
Electrode, Pacemaker, Temporary
2
Product Code
MAB
Marker, Cardiopulmonary Bypass (Vein Marker)
2
Product Code
MAL
Graft, Vascular, Synthetic/Biologic Composite
2
Product Code
MFX
Vessel Guard Or Cover, To Facilitate Revision Surgeries
2
Product Code
MOP
Rotator, Prosthetic Heart Valve
1
Product Code
MZY
Graft, Vascular, Stainless Steel Tunneler
2
Product Code
NHW
Electrode, Pacing And Cardioversion, Temporary, Epicardial
2
Product Code
NKO
System, Balloon, Intra-Aortic And Control, Reprocessed
3
Product Code
OKR
Ventricular Bypass (Assist) Device
3
Product Code
OMH
Pericardial Patch To Facilitate Revision Surgeries
2
Product Code
OMR
Vessel Guard Or Cover
2
Product Code
OTD
Endovascular Suturing System
2
Product Code
OVJ
Pulse Generator, External Pacemaker, Dual Chamber
2
Product Code
PAL
Pulmonic Replacement Heart Valve
F
Product Code
PCK
Pediatric Ventricular Assist Device
F
Product Code
PNJ
Leadless Pacemaker
3
Product Code
PNS
Short-Term Intravascular Filter Catheter
2
Product Code
PSQ
Intracardiac Patch Or Pledget, Biologically Derived
2
Product Code
PST
Aortic Annuloplasty Ring
2
Product Code
QAB
Pacing System Analyzer
2
Product Code
Subpart E—Cardiovascular Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 27 June 2025 at 11:06 pm
CV
/
subpart-d—cardiovascular-prosthetic-devices
/
KRG
/
K842364
View Source
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K842364
510(k) Type
Traditional
Applicant
CARDIAC PACEMAKERS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/24/1984
Days to Decision
98 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
DST
Clip, Vena-Cava
DSW
Bag, Polymeric Mesh, Pacemaker
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
DSZ
Pacemaker Battery
DTA
Tester, Pacemaker Electrode Function
DTB
Permanent Pacemaker Electrode
DTC
Analyzer, Pacemaker Generator Function
DTD
Pacemaker Lead Adaptor
DTE
Pulse-Generator, Pacemaker, External
DTF
Tools, Pacemaker Service
DTG
Magnet, Test, Pacemaker
DTI
Sizer, Heart-Valve, Prosthesis
DTJ
Holder, Heart-Valve, Prosthesis
DTK
Filter, Intravascular, Cardiovascular
DSP
System, Balloon, Intra-Aortic And Control
DSR
Stimulator, Carotid Sinus Nerve
DSS
Clip, Vascular
DXY
Implantable Pacemaker Pulse-Generator
DXZ
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
DYE
Replacement Heart-Valve
DYF
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
KFJ
Materials, Repair Or Replacement, Pacemaker
KRD
Device, Vascular, For Promoting Embolization
KRE
Analyzer, Pacemaker Generator Function, Indirect
KRF
Charger, Pacemaker
KRG
Programmer, Pacemaker
K
93
3278
INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04
K
88
4522
MODEL 5650 OPTIMATE PERSONAL PROGRAMMER
K
88
0738
MODEL 2331T PATIENT PROGRAMMER
K
88
2429
MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004
K
86
4712
MODEL 1740 PERSONAL POCKET PROGRAMMER
K
87
1986
MODEL 5600B PROGRAMMER, PACEMAKER
K
86
3046
ULTRA SOFTWARE MODULE: MODEL 2016
K
86
3045
PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580
K
86
0584
SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN
K
86
0546
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37
P
01
0031
BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D
P
01
0031
APPLICATION SOFTWARE, BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC
P
01
0031
BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE
P
89
0003
MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS
P
88
0086
VICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 5610
P
88
0086
AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
P
83
0045
EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND THE MODEL 3307 V 4.6M SOFTWARE
P
83
0045
VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR
P
83
0045
MODEL 3510 PROGRAMMER AND MODEL 3134 EXTERNAL VIDEO CABLE
P
83
0045
ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND MODEL 3307 V.4.5A SOFTWARE
P
83
0045
ADX PULSE GENERATOR
P
83
0045
IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC
P
83
0045
EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
P
83
0045
IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A
P
83
0045
APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)
P
90
0070
APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)
P
88
0086
AV PLUS DX, MODEL 1368
P
83
0045
MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE
P
83
0045
ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND B-235)
P
83
0045
ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
P
83
0045
IDENTITY PULSE GENERATOR MODEL DR 5370
P
88
0006
REGENCY SC+ PULSE GENERATORS
P
83
0045
INTEGRITY AFX DR MODEL 5346
P
83
0045
MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE
P
83
0045
INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE
P
83
0045
VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE
P
83
0045
INTEGRITY DR MODEL 5336/INTEGRITY SR MODEL 5136
P
83
0045
VENTRITEX ICD'S
P
83
0045
INTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL
P
83
0045
V1. 2A PROGRAMMER SOFTWARE
P
90
0070
TRILOGY/SOLUS II/PARAGON III/PHOENIX III
P
88
0006
V.1 2A PROGRAMMER SOFTWARE
P
88
0006
MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS
P
83
0045
MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS
P
88
0006
MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER
P
83
0045
MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER
P
90
0070
TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ ADDVENT TEMPO
P
83
0045
TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO
P
83
0045
3500/3510 PROGRAMMER
P
83
0045
CARDIAC PACEMAKER PROGRAMMER & BASE STATION
P
88
0086
3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03
P
83
0045
3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03
P
88
0086
AFFINITY SR/DR
P
88
0086
AFFINITY DR & DC; ENTITY DR & DC
P
83
0045
MODEL 3510 PROGRAMMER/3303 SOFTWARE
P
88
0086
MODEL 3510 PROGRAMMER/ 3303 SOFTWARE
P
91
0077
MODEL 2901 PROGRAMMER
P
94
0031
MODEL 2901 PROGRAMMERR SYSTEM
K
84
4484
HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA
K
84
4483
TP 1
K
84
4485
CERYX6, 611, CERYX 3 311 & CERYX 1 111
K
84
2364
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
K
82
0230
PACEMAKER PROGRAMMER 2030
K
81
2761
FLOW-DIRECTED BALLOON THERMODILUTION
K
81
2813
INTERMEDICS PROGRAMMER, MODEL 522-03
K
81
1217
PACEMAKER PROGRAMMER #2010
K
81
0552
CORDIS PACEMAKER PROGRAMMERS 255A & 256A
K
80
0376
EPR-200 PROGRAMMER MODEL 010
K
79
2580
PACEMAKER PROGRAMMER
K
79
1419
OMNICOR PROGRAMMER MODEL 222C
K
79
0220
PACEMAKER PROGRAMMER
K
78
0175
RATE PROGRAMMER MODEL 520
K
77
1855
OMNICOR PROGRAMMER MODEL 222A
KRH
Ring, Annuloplasty
LDF
Electrode, Pacemaker, Temporary
MAB
Marker, Cardiopulmonary Bypass (Vein Marker)
MAL
Graft, Vascular, Synthetic/Biologic Composite
MFX
Vessel Guard Or Cover, To Facilitate Revision Surgeries
MOP
Rotator, Prosthetic Heart Valve
MZY
Graft, Vascular, Stainless Steel Tunneler
NHW
Electrode, Pacing And Cardioversion, Temporary, Epicardial
NKO
System, Balloon, Intra-Aortic And Control, Reprocessed
OKR
Ventricular Bypass (Assist) Device
OMH
Pericardial Patch To Facilitate Revision Surgeries
OMR
Vessel Guard Or Cover
OTD
Endovascular Suturing System
OVJ
Pulse Generator, External Pacemaker, Dual Chamber
PAL
Pulmonic Replacement Heart Valve
PCK
Pediatric Ventricular Assist Device
PNJ
Leadless Pacemaker
PNS
Short-Term Intravascular Filter Catheter
PSQ
Intracardiac Patch Or Pledget, Biologically Derived
PST
Aortic Annuloplasty Ring
QAB
Pacing System Analyzer
Subpart E—Cardiovascular Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Therapeutic Devices
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
CV
/
subpart-d—cardiovascular-prosthetic-devices
/
KRG
/
K842364
View Source
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K842364
510(k) Type
Traditional
Applicant
CARDIAC PACEMAKERS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/24/1984
Days to Decision
98 days