Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

Device Code: 2657

Product Code(s): LJS

Device Classification Information

Device Type ID2657
Device NameCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Regulation DescriptionPercutaneous, Implanted, Long-term Intravascular Catheter.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(k)
CFR Regulation Number880.5970 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLJS
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2657
DeviceCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Product CodeLJS
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPercutaneous, Implanted, Long-term Intravascular Catheter.
CFR Regulation Number880.5970 [🔎]
Premarket Reviews
ManufacturerDecision
AMECO MEDICAL INDUSTRIES
 
SUBSTANTIALLY EQUIVALENT
 1
ANGIODYNAMICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX,
 
SUBSTANTIALLY EQUIVALENT
 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
 
SUBSTANTIALLY EQUIVALENT
 1
C.R. BARD, INC.
 
SUBSTANTIALLY EQUIVALENT
 8
COOK CORPORATED
 
SUBSTANTIALLY EQUIVALENT
 1
COOK, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
MEDCOMP (MEDICAL COMPONENTS)
 
SUBSTANTIALLY EQUIVALENT
 1
MEDCOMP (MEDICAL COMPONENTS, INC.)
 
SUBSTANTIALLY EQUIVALENT
 3
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
 
SUBSTANTIALLY EQUIVALENT
 2
NAVILYST MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT - KIT
 1
 
SUBSTANTIALLY EQUIVALENT
 5
NOSTIX LLC
 
SUBSTANTIALLY EQUIVALENT
 1
ROMEDEX INTERNATIONAL SRL
 
SUBSTANTIALLY EQUIVALENT
 1
VYGON
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Fluid Leak
 467
Break
 249
Leak / Splash
 215
Fracture
 147
Crack
 110
Material Separation
 103
Deformation Due To Compressive Stress
95
Material Deformation
 80
Detachment Of Device Or Device Component
 80
Adverse Event Without Identified Device Or Use Problem
 69
Material Fragmentation
 66
Split
 64
Occlusion Within Device
 59
Unraveled Material
 46
Catheter
 46
Device Dislodged Or Dislocated
 45
Detachment Of Device Component
 45
Kinked
 43
Hole In Material
 40
Difficult To Remove
37
Physical Resistance
 33
Mushroomed
 33
Material Rupture
 31
Burst Container Or Vessel
28
Appropriate Term/Code Not Available
 25
Material Frayed
 25
Defective Component
 20
Difficult To Advance
 20
Migration Or Expulsion Of Device
18
Device Operates Differently Than Expected
 17
Material Integrity Problem
 17
Knotted
 17
Failure To Advance
 16
Guidewire
 15
Partial Blockage
 15
Failure To Infuse
 13
Separation Failure
13
Device Damaged Prior To Use
13
Insufficient Information
 11
Activation, Positioning Or Separation Problem
 11
Material Puncture / Hole
 10
Difficult To Flush
9
Obstruction Of Flow
 9
Backflow
 9
Uncoiled
 9
Malposition Of Device
9
Complete Blockage
 9
Fitting Problem
 8
Cut In Material
 8
Infusion Or Flow Problem
 8
Bent
 8
Connection Problem
 7
Suction Problem
 7
Material Split, Cut Or Torn
 7
Stretched
 7
Device Issue
 7
Aspiration Issue
 6
Use Of Device Problem
 6
Material Twisted / Bent
 6
Migration
 5
Sticking
 5
Incomplete Or Missing Packaging
 5
Torn Material
 5
Device Markings / Labelling Problem
 5
Positioning Problem
 5
Defective Device
 4
Material Perforation
 4
Air Leak
 4
Device Contamination With Chemical Or Other Material
 4
Tear, Rip Or Hole In Device Packaging
 4
Wrinkled
 4
Unknown (for Use When The Device Problem Is Not Known)
 4
Wire
 4
Component Missing
3
Physical Property Issue
 3
Tip
 3
Improper Or Incorrect Procedure Or Method
 3
Product Quality Problem
 3
Pressure Problem
 3
Collapse
 3
Loose Or Intermittent Connection
 3
Material Distortion
 2
Hub
 2
Component Falling
 2
Disconnection
 2
Entrapment Of Device
 2
Restricted Flow Rate
 2
Difficult To Insert
 2
Other (for Use When An Appropriate Device Code Cannot Be Identified)
 2
Material Too Soft / Flexible
 2
Reflux Within Device
 2
Peeled / Delaminated
 2
Decrease In Pressure
 2
Physical Resistance / Sticking
 2
Folded
 2
Contamination During Use
 2
Missing Information
 2
Patient-Device Incompatibility
 2
Material Disintegration
 2
Disassembly
 2
Total Device Problems 2770
Recalls
Manufacturer Recall Class Date Posted
1
Angiodynamics Inc. (Navilyst Medical Inc.)
 II Dec-11-2018
2
Angiodynamics Inc. (Navilyst Medical Inc.)
 II Jun-14-2018
3
Angiodynamics Inc. (Navilyst Medical Inc.)
 II Dec-14-2017
4
Angiodynamics Inc. (Navilyst Medical Inc.)
 II Dec-07-2016
5
Angiodynamics Inc. (Navilyst Medical Inc.)
 II Dec-05-2016
6
Arrow International Inc
 II Sep-19-2018
7
Arrow International Inc
 II Jul-08-2018
8
Arrow International Inc
 II May-30-2018
9
Arrow International Inc
 II Apr-10-2018
10
Arrow International Inc
 II Mar-14-2018
11
Arrow International Inc
 II Feb-22-2018
12
Arrow International Inc
 II Feb-13-2018
13
Arrow International Inc
 II Nov-28-2017
14
Arrow International Inc
 II Jun-27-2017
15
Arrow International Inc
 II Jun-12-2017
16
Arrow International Inc
 II Mar-08-2017
17
Arrow International Inc
 II Feb-22-2017
18
Arrow International Inc
 II Sep-09-2016
19
Arrow International Inc
 II Nov-04-2015
20
Arrow International Inc
 II Oct-15-2015
21
Arrow International Inc
 II Aug-25-2015
22
Arrow International Inc
 II Apr-24-2014
23
Bard Access Systems
 II Sep-23-2015
24
Bard Access Systems
 III Jul-08-2015
25
Bard Access Systems
 II Mar-13-2015
26
Bard Access Systems Inc.
 II Feb-06-2018
27
Navilyst Medical, Inc
 II Oct-07-2014
28
Navilyst Medical, Inc., An AngioDyamics Company
 II Jun-14-2016
29
Pfm Medical Inc
 II Dec-12-2014
30
Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc.
 II Feb-21-2018
TPLC Last Update: 2019-04-02 20:16:50
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