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
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
K
24
0078
Fogarty Thru-Lumen Embolectomy Catheter
2
Cleared 510(K)
K
24
1330
Fogarty Fortis Arterial Embolectomy Catheter
2
Cleared 510(K)
K
23
3819
Fogarty Venous Thrombectomy Catheters
2
Cleared 510(K)
K
23
3820
Fogarty Arterial Embolectomy Catheter with Gate Valve
2
Cleared 510(K)
K
23
3619
Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
2
Cleared 510(K)
K
21
3771
Merlin Aspiration System
2
Cleared 510(K)
K
20
2049
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
2
Cleared 510(K)
K
19
3379
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
2
Cleared 510(K)
K
16
3031
Bunegin-Albin Air Aspiration Set
2
Cleared 510(K)
K
16
3353
Needle's Eye Snare Retrieval Set - 54cm
2
Cleared 510(K)
K
15
2335
Export Advance Aspiration Catheter
2
Cleared 510(K)
K
10
0842
PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM
2
Cleared 510(K)
K
10
0840
EMBO PLUS EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
08
1573
MEDTRONIC EXPORT AP CATHETER
2
Cleared 510(K)
K
02
2145
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
2
Cleared 510(K)
K
02
0634
MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
2
Cleared 510(K)
K
01
1783
MULTI-SNARE SET
2
Cleared 510(K)
K
00
2627
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
2
Cleared 510(K)
K
99
2933
LEMAITRE IRRIGATION CATHETER
2
Cleared 510(K)
K
99
2934
LEMAITRE VENOUS THROMBECTOMY CATHETER
2
Cleared 510(K)
K
99
2940
LEMAITRE BALLOON CATHETER WITH IRRIGATION
2
Cleared 510(K)
K
99
2368
LEMAITRE EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
97
3477
BIOSENSORS EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
98
2141
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
2
Cleared 510(K)
K
97
1314
DCAT EMBOLECTOMY CATHETER SYSTEM
2
Cleared 510(K)
K
97
2511
AMPLATZ GOOSE NECK SNARE KIT/ CATHETER
2
Cleared 510(K)
K
97
3465
LATIS GRAFT CLEANING CATHETER
2
Cleared 510(K)
K
97
4335
EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
2
Cleared 510(K)
K
97
2572
SINGLE LUMEN EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
97
2623
LMI IRRIGATION CATHETER (IGR)
2
Cleared 510(K)
K
97
0657
LMI THROMBECTOMY CATHETER
2
Cleared 510(K)
K
97
0762
DUAL LUMEN EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
96
1883
VERSA-CATH ARTERIAL CATHETER
2
Cleared 510(K)
K
96
1992
NEEDLE'S EYE SNARE
2
Cleared 510(K)
K
96
1716
VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE
2
Cleared 510(K)
K
95
4760
LMI ARTERIAL EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
95
5125
LMI OCCLUSION CATHETER
2
Cleared 510(K)
K
95
0586
AVD INTIMAX THROMBECTOMY CATHETER
2
Cleared 510(K)
K
93
5405
ARTERIAL EMBOLECTOMY
2
Cleared 510(K)
K
92
0823
WELTER SNARE RETRIEVER
2
Cleared 510(K)
K
92
0871
J-LLOYD ARTERIAL EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
91
4880
DUAL BALLOON EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
91
0372
INTIMAX THROMBECTOMY CATHETER
2
Cleared 510(K)
K
90
5139
CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
90
2327
EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
90
1502
AMPLATZ GOOSE-NECK SNARE
2
Cleared 510(K)
K
90
1627
ARTERIAL EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
90
0311
ARTERIAL EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
90
1625
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
2
Cleared 510(K)
K
89
7184
3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS
2
Cleared 510(K)
K
88
3852
CATHETER, CARDIOVASCULAR, BALLOON TYPE
2
Cleared 510(K)
K
89
4681
REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
89
1021
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER
2
Cleared 510(K)
K
89
3680
SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.
2
Cleared 510(K)
K
89
2410
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
88
1455
EMBOLECTOMY CATHETER(MODIFIED)
2
Cleared 510(K)
K
87
2485
CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)
2
Cleared 510(K)
K
86
4330
SHEAR FORCE GAUGE
2
Cleared 510(K)
K
86
4062
PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)
2
Cleared 510(K)
K
86
4007
EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER
2
Cleared 510(K)
K
85
3625
NOVA ARTERIAL EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
85
0015
POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
84
0198
ARTERIAL EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
83
2044
SHILEY MULTIPRO CATHETER
2
Cleared 510(K)
K
83
2023
EMBOLECTOMY CATHETER
2
Cleared 510(K)
K
82
0646
ATRAC TM MULTIPURPOSE BALLOON CATHETER
2
Cleared 510(K)
K
81
2640
URE SIL EMBOLECTOMY/THROMBECTOMY CATH
2
Cleared 510(K)
K
80
1650
DESERET EMBOLECTOMY/THROMBECTOMY CATH.
2
Cleared 510(K)
K
79
0838
ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)
2
Cleared 510(K)
K
78
0762
EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE
2
Cleared 510(K)
K
78
0244
CATHETERS, ARTERIAL EMBOLECTOMY
2
Cleared 510(K)
K
77
0714
CATHETER, ARTERIAL EMBOLECTOMY
2
Cleared 510(K)
K
77
0569
CATHETER, EMBOLECTOMY, UMI
2
Cleared 510(K)
K
76
1031
ELECATH ARTERIAL EMBOLECTOMY CATHETER
2
Cleared 510(K)
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
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 16 May 2025 at 11:05 pm
CV
/
subpart-f—cardiovascular-therapeutic-devices
/
DXE
/
K973465
View Source
LATIS GRAFT CLEANING CATHETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K973465
510(k) Type
Traditional
Applicant
APPLIED MEDICAL RESOURCES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/19/1998
Days to Decision
160 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
K
24
0078
Fogarty Thru-Lumen Embolectomy Catheter
K
24
1330
Fogarty Fortis Arterial Embolectomy Catheter
K
23
3819
Fogarty Venous Thrombectomy Catheters
K
23
3820
Fogarty Arterial Embolectomy Catheter with Gate Valve
K
23
3619
Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
K
21
3771
Merlin Aspiration System
K
20
2049
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
K
19
3379
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
K
16
3031
Bunegin-Albin Air Aspiration Set
K
16
3353
Needle's Eye Snare Retrieval Set - 54cm
K
15
2335
Export Advance Aspiration Catheter
K
10
0842
PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM
K
10
0840
EMBO PLUS EMBOLECTOMY CATHETER
K
08
1573
MEDTRONIC EXPORT AP CATHETER
K
02
2145
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
K
02
0634
MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K
01
1783
MULTI-SNARE SET
K
00
2627
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K
99
2933
LEMAITRE IRRIGATION CATHETER
K
99
2934
LEMAITRE VENOUS THROMBECTOMY CATHETER
K
99
2940
LEMAITRE BALLOON CATHETER WITH IRRIGATION
K
99
2368
LEMAITRE EMBOLECTOMY CATHETER
K
97
3477
BIOSENSORS EMBOLECTOMY CATHETER
K
98
2141
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
K
97
1314
DCAT EMBOLECTOMY CATHETER SYSTEM
K
97
2511
AMPLATZ GOOSE NECK SNARE KIT/ CATHETER
K
97
3465
LATIS GRAFT CLEANING CATHETER
K
97
4335
EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
K
97
2572
SINGLE LUMEN EMBOLECTOMY CATHETER
K
97
2623
LMI IRRIGATION CATHETER (IGR)
K
97
0657
LMI THROMBECTOMY CATHETER
K
97
0762
DUAL LUMEN EMBOLECTOMY CATHETER
K
96
1883
VERSA-CATH ARTERIAL CATHETER
K
96
1992
NEEDLE'S EYE SNARE
K
96
1716
VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE
K
95
4760
LMI ARTERIAL EMBOLECTOMY CATHETER
K
95
5125
LMI OCCLUSION CATHETER
K
95
0586
AVD INTIMAX THROMBECTOMY CATHETER
K
93
5405
ARTERIAL EMBOLECTOMY
K
92
0823
WELTER SNARE RETRIEVER
K
92
0871
J-LLOYD ARTERIAL EMBOLECTOMY CATHETER
K
91
4880
DUAL BALLOON EMBOLECTOMY CATHETER
K
91
0372
INTIMAX THROMBECTOMY CATHETER
K
90
5139
CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER
K
90
2327
EMBOLECTOMY CATHETER
K
90
1502
AMPLATZ GOOSE-NECK SNARE
K
90
1627
ARTERIAL EMBOLECTOMY CATHETER
K
90
0311
ARTERIAL EMBOLECTOMY CATHETER
K
90
1625
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
K
89
7184
3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS
K
88
3852
CATHETER, CARDIOVASCULAR, BALLOON TYPE
K
89
4681
REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER
K
89
1021
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER
K
89
3680
SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.
K
89
2410
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
K
88
1455
EMBOLECTOMY CATHETER(MODIFIED)
K
87
2485
CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)
K
86
4330
SHEAR FORCE GAUGE
K
86
4062
PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)
K
86
4007
EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER
K
85
3625
NOVA ARTERIAL EMBOLECTOMY CATHETER
K
85
0015
POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER
K
84
0198
ARTERIAL EMBOLECTOMY CATHETER
K
83
2044
SHILEY MULTIPRO CATHETER
K
83
2023
EMBOLECTOMY CATHETER
K
82
0646
ATRAC TM MULTIPURPOSE BALLOON CATHETER
K
81
2640
URE SIL EMBOLECTOMY/THROMBECTOMY CATH
K
80
1650
DESERET EMBOLECTOMY/THROMBECTOMY CATH.
K
79
0838
ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)
K
78
0762
EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE
K
78
0244
CATHETERS, ARTERIAL EMBOLECTOMY
K
77
0714
CATHETER, ARTERIAL EMBOLECTOMY
K
77
0569
CATHETER, EMBOLECTOMY, UMI
K
76
1031
ELECATH ARTERIAL EMBOLECTOMY CATHETER
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
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
/
DXE
/
K973465
View Source
LATIS GRAFT CLEANING CATHETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K973465
510(k) Type
Traditional
Applicant
APPLIED MEDICAL RESOURCES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/19/1998
Days to Decision
160 days
Submission Type
Summary