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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Miscellaneous
Miscellaneous
QOD
Extracorporeal Circuit And Accessories For Long Term Respiratory Cariodpulmonary Failure
N
Product Code
QRJ
Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
2
Product Code
KPK
Marker, Ostia, Aorto-Saphenous Vein
2
Product Code
DSQ
Ventricular (Assist) Bypass
3
Product Code
FZC
Prosthesis, Arterial Graft, Bovine Carotid Artery
3
Product Code
LOT
Pulse-Generator, Program Module
3
Product Code
LOZ
Artificial Heart
3
Product Code
LPA
System, Esophageal Pacing
3
Product Code
LPB
Cardiac Ablation Percutaneous Catheter
3
Product Code
LPC
Device, Angioplasty, Laser, Coronary
3
Product Code
LWO
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
3
Product Code
LWP
Implantable Pulse Generator, Pacemaker (Non-Crt)
3
Product Code
LWQ
Heart-Valve, Mechanical
3
Product Code
LWR
Heart-Valve, Non-Allograft Tissue
3
Product Code
LWS
Implantable Cardioverter Defibrillator (Non-Crt)
3
Product Code
LWT
Occluder, Balloon, Vena-Cava
3
Product Code
LWW
Pulse-Generator, Single Chamber, Single
3
Product Code
LWX
Device. Laser Peripheral Angioplasty
3
Product Code
LWZ
Tissue Graft Of Less Than 6mm
3
Product Code
LXA
Tissue Graft Of 6mm And Greater
3
Product Code
MAD
Catheter, Percutaneous (Valvuloplasty)
3
Product Code
MAE
Occluder, Patent Ductus, Arteriosus
3
Product Code
MAF
Stent, Coronary
3
Product Code
MCX
Catheter, Coronary, Atherectomy
3
Product Code
MFA
Device, Removal, Pacemaker Electrode, Percutaneous
3
Product Code
MGB
Device, Hemostasis, Vascular
3
Product Code
MIE
Heart-Valve, Allograft
3
Product Code
MIH
System, Endovascular Graft, Aortic Aneurysm Treatment
3
Product Code
MIR
Shunt, Portosystemic, Endoprosthesis
3
Product Code
MLV
Transcatheter Septal Occluder
3
Product Code
MNO
System, Laser, Transmyocardial Revascularization
3
Product Code
MOM
System, Hemodynamic, Implantable
3
Product Code
MOU
Intravascular Radiation Delivery System
3
Product Code
MRM
Defibrillator, Implantable, Dual-Chamber
3
Product Code
MTE
System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
3
Product Code
MUQ
Glue, Surgical, Arteries
3
Product Code
MVK
Wearable Automated External Defibrillator
3
Product Code
MWG
System, Oxygen, Aqueous
3
Product Code
MWH
Pulmonic Valved Conduit
F
Product Code
NAP
Cardiac Support Mesh Wrap
N
Product Code
NAV
Graft, Bypass, Coronary Artery
F
Product Code
NGV
System, Appendage Closure, Left Atrial
3
Product Code
NIK
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
3
Product Code
NIM
Stent, Carotid
3
Product Code
NIN
Stent, Renal
3
Product Code
NIO
Stent, Iliac
3
Product Code
NIP
Stent, Superficial Femoral Artery
3
Product Code
NIQ
Coronary Drug-Eluting Stent
3
Product Code
NIU
Stent, Superficial Femoral Artery, Drug-Eluting
3
Product Code
NIV
Coronary Covered Stent
F
Product Code
NKE
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
3
Product Code
NKM
Mitral Valve Repair Devices
3
Product Code
NPT
Aortic Valve, Prosthesis, Percutaneously Delivered
3
Product Code
NPU
Prosthesis, Mitral Valve, Percutaneously Delivered
3
Product Code
NPV
Pulmonary Valve Prosthesis Percutaneously Delivered
F
Product Code
NVN
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
3
Product Code
NVY
Permanent Defibrillator Electrodes
3
Product Code
NVZ
Pulse Generator, Permanent, Implantable
3
Product Code
NWX
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
3
Product Code
OAD
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
3
Product Code
OAE
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
3
Product Code
OBC
Occluder, Internal Vessel, Temporary
3
Product Code
OBD
Barrier, Adhesion, Cardiovascular
3
Product Code
OCM
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
3
Product Code
ODT
Tissue Adhesive, Aortic Aneurysmorrhaphy
F
Product Code
OHA
Heart Valve, More Than Minimally Manipulated Allograft
U
Product Code
OJE
Right Ventricular Bypass (Assist) Device
F
Product Code
OJX
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
3
Product Code
ONU
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
3
Product Code
OSR
Pacemaker/Icd/Crt Non-Implanted Components
3
Product Code
OZD
Temporary Non-Roller Type Left Heart Support Blood Pump
3
Product Code
OZG
Transcatheter Septal Occluder (Atrial)
3
Product Code
OZH
Transcatheter Septal Occluder (Ventricular)
3
Product Code
PAP
Aortic Heart Valve, More Than Minimally Manipulated Allograft
F
Product Code
PCW
Implantable Pulse Generator, Programmer And Battery Charger
N
Product Code
PCX
Artificial Chordae Tendinae Delivery System
N
Product Code
PFV
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
3
Product Code
PIZ
Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve
3
Product Code
PJQ
Agent, Occluding, Vascular, Permanent
3
Product Code
PKK
Stent Delivery System
N
Product Code
PNF
Aortic Stent
3
Product Code
PNY
Absorbable Coronary Drug-Eluting Stent
3
Product Code
PRC
Drug-Coated Peripheral Transluminal Angioplasty Catheter
3
Product Code
PRL
Iliac Covered Stent, Arterial
3
Product Code
QAN
Stent, Iliac Vein
3
Product Code
QBI
Acute Coronary Syndrome Event Detector
3
Product Code
QCT
Scaffold, Dissection Repair
3
Product Code
QFV
Implantable Pulse Generator
3
Product Code
QLJ
Patient Monitor With Independent Remote Display And Operation
N
Product Code
QLL
Left Ventricular Ejection Fraction Screening Tool
N
Product Code
QLM
Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool
N
Product Code
QLN
Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19
N
Product Code
QMG
Shockwave Intravascular Lithotripsy System
3
Product Code
QNY
Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring
N
Product Code
QNZ
Powered Communication System For Emergency Use
N
Product Code
QOA
Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening
N
Product Code
QOC
Temporary Non-Roller Type Left Or Right Heart Support Blood Pump
N
Product Code
QIK
Organ Care System (Ocs) Heart System
3
Product Code
QSK
Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
3
Product Code
QWA
Cardiovascular Delivery Catheter System Positioning And Stabilization Device
1
Product Code
QWM
Stent Graft, Bypass, Superficial Femoral Artery
3
Product Code
QXO
Cardiovascular Machine Learning-Based Notification Software
2
Product Code
QWC
Pulmonary Stent
3
Product Code
QVQ
Extravascular Support For An Arteriovenous Fistula For Vascular Access
3
Product Code
QXV
Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
2
Product Code
QWN
Stent Graft, Infrapopliteal, Venous Arterialization
3
Product Code
QXU
Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
2
Product Code
QXX
Coronary Artery Disease Machine Learning-Based Notification Software
2
Product Code
QYE
Reduced Ejection Fraction Machine Learning-Based Notification Software
2
Product Code
QVG
Embolization Agent, Vascular
3
Product Code
QYI
Ablation Catheter, Renal Denervation
3
Product Code
QYU
Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
2
Product Code
QZI
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
3
Product Code
QZK
Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
3
Product Code
QZU
Temporary Embolization Assist Device, Peripheral
2
Product Code
NPW
Percutaneously Delivered Prostheses And Tricuspid Valves
3
Product Code
OOB
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
3
Product Code
NPS
Tricuspid Valve Repair Device, Percutaneously Delivered
3
Product Code
SAT
Pulmonary Hypertension Machine Learning-Based Notification Software
2
Product Code
SBK
Artificial Chordae Tendineae Surgical Replacement System
2
Product Code
SBQ
Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
2
Product Code
QXY
Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification
2
Product Code
SCZ
Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
2
Product Code
NXW
Scaffold, Infrapopliteal, Absorbable
3
Product Code
Submissions with No Product Code
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
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 21 February 2025 at 11:05 pm
CV
/
CV-misc
/
no-product-code
Submissions with No Product Code
Page Type
Miscellaneous
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Miscellaneous
QOD
Extracorporeal Circuit And Accessories For Long Term Respiratory Cariodpulmonary Failure
QRJ
Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
KPK
Marker, Ostia, Aorto-Saphenous Vein
DSQ
Ventricular (Assist) Bypass
FZC
Prosthesis, Arterial Graft, Bovine Carotid Artery
LOT
Pulse-Generator, Program Module
LOZ
Artificial Heart
LPA
System, Esophageal Pacing
LPB
Cardiac Ablation Percutaneous Catheter
LPC
Device, Angioplasty, Laser, Coronary
LWO
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
LWP
Implantable Pulse Generator, Pacemaker (Non-Crt)
LWQ
Heart-Valve, Mechanical
LWR
Heart-Valve, Non-Allograft Tissue
LWS
Implantable Cardioverter Defibrillator (Non-Crt)
LWT
Occluder, Balloon, Vena-Cava
LWW
Pulse-Generator, Single Chamber, Single
LWX
Device. Laser Peripheral Angioplasty
LWZ
Tissue Graft Of Less Than 6mm
LXA
Tissue Graft Of 6mm And Greater
MAD
Catheter, Percutaneous (Valvuloplasty)
MAE
Occluder, Patent Ductus, Arteriosus
MAF
Stent, Coronary
MCX
Catheter, Coronary, Atherectomy
MFA
Device, Removal, Pacemaker Electrode, Percutaneous
MGB
Device, Hemostasis, Vascular
MIE
Heart-Valve, Allograft
MIH
System, Endovascular Graft, Aortic Aneurysm Treatment
MIR
Shunt, Portosystemic, Endoprosthesis
MLV
Transcatheter Septal Occluder
MNO
System, Laser, Transmyocardial Revascularization
MOM
System, Hemodynamic, Implantable
MOU
Intravascular Radiation Delivery System
MRM
Defibrillator, Implantable, Dual-Chamber
MTE
System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
MUQ
Glue, Surgical, Arteries
MVK
Wearable Automated External Defibrillator
MWG
System, Oxygen, Aqueous
MWH
Pulmonic Valved Conduit
NAP
Cardiac Support Mesh Wrap
NAV
Graft, Bypass, Coronary Artery
NGV
System, Appendage Closure, Left Atrial
NIK
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
NIM
Stent, Carotid
NIN
Stent, Renal
NIO
Stent, Iliac
NIP
Stent, Superficial Femoral Artery
NIQ
Coronary Drug-Eluting Stent
NIU
Stent, Superficial Femoral Artery, Drug-Eluting
NIV
Coronary Covered Stent
NKE
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
NKM
Mitral Valve Repair Devices
NPT
Aortic Valve, Prosthesis, Percutaneously Delivered
NPU
Prosthesis, Mitral Valve, Percutaneously Delivered
NPV
Pulmonary Valve Prosthesis Percutaneously Delivered
NVN
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
NVY
Permanent Defibrillator Electrodes
NVZ
Pulse Generator, Permanent, Implantable
NWX
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
OAD
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
OAE
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
OBC
Occluder, Internal Vessel, Temporary
OBD
Barrier, Adhesion, Cardiovascular
OCM
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
ODT
Tissue Adhesive, Aortic Aneurysmorrhaphy
OHA
Heart Valve, More Than Minimally Manipulated Allograft
OJE
Right Ventricular Bypass (Assist) Device
OJX
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
ONU
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
OSR
Pacemaker/Icd/Crt Non-Implanted Components
OZD
Temporary Non-Roller Type Left Heart Support Blood Pump
OZG
Transcatheter Septal Occluder (Atrial)
OZH
Transcatheter Septal Occluder (Ventricular)
PAP
Aortic Heart Valve, More Than Minimally Manipulated Allograft
PCW
Implantable Pulse Generator, Programmer And Battery Charger
PCX
Artificial Chordae Tendinae Delivery System
PFV
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
PIZ
Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve
PJQ
Agent, Occluding, Vascular, Permanent
PKK
Stent Delivery System
PNF
Aortic Stent
PNY
Absorbable Coronary Drug-Eluting Stent
PRC
Drug-Coated Peripheral Transluminal Angioplasty Catheter
PRL
Iliac Covered Stent, Arterial
QAN
Stent, Iliac Vein
QBI
Acute Coronary Syndrome Event Detector
QCT
Scaffold, Dissection Repair
QFV
Implantable Pulse Generator
QLJ
Patient Monitor With Independent Remote Display And Operation
QLL
Left Ventricular Ejection Fraction Screening Tool
QLM
Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool
QLN
Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19
QMG
Shockwave Intravascular Lithotripsy System
QNY
Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring
QNZ
Powered Communication System For Emergency Use
QOA
Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening
QOC
Temporary Non-Roller Type Left Or Right Heart Support Blood Pump
QIK
Organ Care System (Ocs) Heart System
QSK
Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
QWA
Cardiovascular Delivery Catheter System Positioning And Stabilization Device
QWM
Stent Graft, Bypass, Superficial Femoral Artery
QXO
Cardiovascular Machine Learning-Based Notification Software
QWC
Pulmonary Stent
QVQ
Extravascular Support For An Arteriovenous Fistula For Vascular Access
QXV
Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
QWN
Stent Graft, Infrapopliteal, Venous Arterialization
QXU
Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
QXX
Coronary Artery Disease Machine Learning-Based Notification Software
QYE
Reduced Ejection Fraction Machine Learning-Based Notification Software
QVG
Embolization Agent, Vascular
QYI
Ablation Catheter, Renal Denervation
QYU
Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
QZI
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
QZK
Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
QZU
Temporary Embolization Assist Device, Peripheral
NPW
Percutaneously Delivered Prostheses And Tricuspid Valves
OOB
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
NPS
Tricuspid Valve Repair Device, Percutaneously Delivered
SAT
Pulmonary Hypertension Machine Learning-Based Notification Software
SBK
Artificial Chordae Tendineae Surgical Replacement System
SBQ
Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
QXY
Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification
SCZ
Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
NXW
Scaffold, Infrapopliteal, Absorbable
Submissions with No Product Code
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
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
/
CV-misc
/
no-product-code
Submissions with No Product Code
Page Type
Miscellaneous