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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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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
DRK
Dc-Defibrillator, High Energy, (Including Paddles)
3
Product Code
DRL
Tester, Defibrillator
2
Product Code
DRM
Compressor, Cardiac, External
2
Product Code
DRN
Device, Counter-Pulsating, External
2
Product Code
DRO
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
2
Product Code
DRP
Tourniquet, Automatic Rotating
2
Product Code
DWJ
System, Thermal Regulating
2
Product Code
DXE
Catheter, Embolectomy
2
Product Code
DXF
Catheter, Septostomy
2
Product Code
JOW
Sleeve, Limb, Compressible
2
Product Code
LDD
Dc-Defibrillator, Low-Energy, (Including Paddles)
2
Product Code
LHX
Trousers, Anti-Shock
2
Product Code
LIX
Aid, Cardiopulmonary Resuscitation
2
Product Code
LOX
Catheters, Transluminal Coronary Angioplasty, Percutaneous
2
Product Code
MKJ
Automated External Defibrillators (Non-Wearable)
3
Product Code
MMX
Device, Percutaneous Retrieval
2
Product Code
K
24
2776
LimFlow V-Ceiver
2
Cleared 510(K)
K
24
1259
Amplatz Goose Neck Snare Kit
2
Cleared 510(K)
K
23
2443
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
2
Cleared 510(K)
K
22
2254
Gunther Tulip Vena Cava Filter Retrieval Set
2
Cleared 510(K)
K
22
2083
LimFlow V-Ceiver
2
Cleared 510(K)
K
21
2988
ONO Retrieval Device
2
Cleared 510(K)
K
21
3494
Aveir Retrieval Catheter
2
Cleared 510(K)
K
20
0963
Halo Single-Loop Microsnare Kit
2
Cleared 510(K)
K
20
0268
Halo™ Single-Loop Snare Kit
2
Cleared 510(K)
K
19
3507
Merit ONE Snare System
2
Cleared 510(K)
K
19
1758
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
2
Cleared 510(K)
K
18
1757
Günther Tulip® Vena Cava Filter Retrieval Set
2
Cleared 510(K)
K
17
0987
Captus Vascular Retrieval System
2
Cleared 510(K)
K
16
3307
Expro Elite Snare, Sympro Elite Snare
2
Cleared 510(K)
K
16
0593
Indy OTW Vascular Retriever
2
Cleared 510(K)
K
15
2136
Recovery Cone Removal System
2
Cleared 510(K)
K
15
2560
Bard Snare Retrieval Kit
2
Cleared 510(K)
K
15
1497
EN Snare Endovascular Snare System
2
Cleared 510(K)
K
14
2265
ONE Snare Endovascular Microsnare System
2
Cleared 510(K)
K
13
3681
CRUX SNARE FILTER RETRIEVAL SET
2
Cleared 510(K)
K
12
2088
MERIT ONE SNARE SYSTEM
2
Cleared 510(K)
K
11
2185
FOURSNARE VASCULAR RETRIEVAL SNARE
2
Cleared 510(K)
K
10
2484
SEQURE SNARE SYSTEM
2
Cleared 510(K)
K
09
2343
EN SNARE ENDOVASCULAR SNARE SYSTEM
2
Cleared 510(K)
K
09
1563
RECRUIT MICROCATHETER
2
Cleared 510(K)
K
07
1457
MODIFICATION TO RADIUS SNARE
2
Cleared 510(K)
K
05
0926
TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060
2
Cleared 510(K)
K
03
3188
TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050
2
Cleared 510(K)
K
02
2201
RADIUS MICRO SNARE
2
Cleared 510(K)
K
02
1441
RADIUS SNARE
2
Cleared 510(K)
K
02
1606
EN-SNARE ENDOVASCULAR SNARE AND CATHETER
2
Cleared 510(K)
K
01
4109
IN-TIME RETRIEVAL DEVICE
2
Cleared 510(K)
MPC
Atrial Defibrillator
3
Product Code
MPD
Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
2
Product Code
MPE
Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker
2
Product Code
NSA
Over-The-Counter Automated External Defibrillator
3
Product Code
NZE
Hyperthermia Monitor
2
Product Code
PJB
Catheter Remote Control System
2
Product Code
PLA
Esophageal Thermal Regulation And Gastric Suctioning Device
2
Product Code
PMJ
Cpr Aid Feedback Device (No Software)
2
Product Code
PMK
Cpr Aid Device Without Feedback
1
Product Code
PPS
Sleeve, Head And Neck, Compressible
2
Product Code
QEW
Peripheral Mechanical Thrombectomy With Aspiration
2
Product Code
QEX
Coronary Mechanical Thrombectomy With Aspiration
2
Product Code
QEY
Mechanical Thrombolysis Catheter
2
Product Code
QEZ
Aspiration Thrombectomy Catheter
2
Product Code
QLZ
Septostomy Catheter, Reprocessed
2
Product Code
QMS
Adjunctive Open Loop Fluid Therapy Recommender
2
Product Code
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 23 May 2025 at 11:06 pm
CV
/
subpart-f—cardiovascular-therapeutic-devices
/
MMX
/
K151497
View Source
EN Snare Endovascular Snare System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151497
510(k) Type
Special
Applicant
MERIT MEDICAL SYSTEMS INC
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
7/1/2015
Days to Decision
27 days
Submission Type
Summary
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
Subpart E—Cardiovascular Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
DRK
Dc-Defibrillator, High Energy, (Including Paddles)
DRL
Tester, Defibrillator
DRM
Compressor, Cardiac, External
DRN
Device, Counter-Pulsating, External
DRO
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
DRP
Tourniquet, Automatic Rotating
DWJ
System, Thermal Regulating
DXE
Catheter, Embolectomy
DXF
Catheter, Septostomy
JOW
Sleeve, Limb, Compressible
LDD
Dc-Defibrillator, Low-Energy, (Including Paddles)
LHX
Trousers, Anti-Shock
LIX
Aid, Cardiopulmonary Resuscitation
LOX
Catheters, Transluminal Coronary Angioplasty, Percutaneous
MKJ
Automated External Defibrillators (Non-Wearable)
MMX
Device, Percutaneous Retrieval
K
24
2776
LimFlow V-Ceiver
K
24
1259
Amplatz Goose Neck Snare Kit
K
23
2443
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
K
22
2254
Gunther Tulip Vena Cava Filter Retrieval Set
K
22
2083
LimFlow V-Ceiver
K
21
2988
ONO Retrieval Device
K
21
3494
Aveir Retrieval Catheter
K
20
0963
Halo Single-Loop Microsnare Kit
K
20
0268
Halo™ Single-Loop Snare Kit
K
19
3507
Merit ONE Snare System
K
19
1758
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
K
18
1757
Günther Tulip® Vena Cava Filter Retrieval Set
K
17
0987
Captus Vascular Retrieval System
K
16
3307
Expro Elite Snare, Sympro Elite Snare
K
16
0593
Indy OTW Vascular Retriever
K
15
2136
Recovery Cone Removal System
K
15
2560
Bard Snare Retrieval Kit
K
15
1497
EN Snare Endovascular Snare System
K
14
2265
ONE Snare Endovascular Microsnare System
K
13
3681
CRUX SNARE FILTER RETRIEVAL SET
K
12
2088
MERIT ONE SNARE SYSTEM
K
11
2185
FOURSNARE VASCULAR RETRIEVAL SNARE
K
10
2484
SEQURE SNARE SYSTEM
K
09
2343
EN SNARE ENDOVASCULAR SNARE SYSTEM
K
09
1563
RECRUIT MICROCATHETER
K
07
1457
MODIFICATION TO RADIUS SNARE
K
05
0926
TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060
K
03
3188
TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050
K
02
2201
RADIUS MICRO SNARE
K
02
1441
RADIUS SNARE
K
02
1606
EN-SNARE ENDOVASCULAR SNARE AND CATHETER
K
01
4109
IN-TIME RETRIEVAL DEVICE
MPC
Atrial Defibrillator
MPD
Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
MPE
Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker
NSA
Over-The-Counter Automated External Defibrillator
NZE
Hyperthermia Monitor
PJB
Catheter Remote Control System
PLA
Esophageal Thermal Regulation And Gastric Suctioning Device
PMJ
Cpr Aid Feedback Device (No Software)
PMK
Cpr Aid Device Without Feedback
PPS
Sleeve, Head And Neck, Compressible
QEW
Peripheral Mechanical Thrombectomy With Aspiration
QEX
Coronary Mechanical Thrombectomy With Aspiration
QEY
Mechanical Thrombolysis Catheter
QEZ
Aspiration Thrombectomy Catheter
QLZ
Septostomy Catheter, Reprocessed
QMS
Adjunctive Open Loop Fluid Therapy Recommender
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-f—cardiovascular-therapeutic-devices
/
MMX
/
K151497
View Source
EN Snare Endovascular Snare System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151497
510(k) Type
Special
Applicant
MERIT MEDICAL SYSTEMS INC
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
7/1/2015
Days to Decision
27 days
Submission Type
Summary