Catheter, Percutaneous

Device Code: 741

Product Code(s): DQY

Device Classification Information

Device Type ID741
Device NameCatheter, Percutaneous
Regulation DescriptionPercutaneous Catheter.
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Peripheral Interventional Devices Branch (PIDB)
Submission Type510(k)
CFR Regulation Number870.1250 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDQY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID741
DeviceCatheter, Percutaneous
Product CodeDQY
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPercutaneous Catheter.
CFR Regulation Number870.1250 [🔎]
Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
 
SUBSTANTIALLY EQUIVALENT
 2
ACCESS SCIENTIFIC, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
ADVANCED CATHETER THERAPIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
ASAHI
 
SUBSTANTIALLY EQUIVALENT
 7
ASAHI INTECC CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 7
ASHITAKA FACTORY OF TERUMO CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
BIOTRONIK GMBG & CO.
 
SUBSTANTIALLY EQUIVALENT
 1
 
SUBSTANTIALLY EQUIVALENT - KIT
 1
BIOTRONIK, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
 
SUBSTANTIALLY EQUIVALENT - KIT
 1
BOSTON SCIENTIFIC
 
SUBSTANTIALLY EQUIVALENT
 2
BOSTON SCIENTIFIC CORP.
 
SUBSTANTIALLY EQUIVALENT
 7
BOSTON SCIENTIFIC CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 5
C. R. BARD, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
C.R. BARD, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
CARDIOVASCULAR SYSTEMS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
CATHERA, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
CODMAN & SHURTLEFF, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
CONCENTRIC MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
COOK, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
CORDIS CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
CORDIS CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
CRUZAR MEDSYSTEMS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
CURATIA MEDICAL LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
CURATIVE MEDICAL TECHNOLOGY LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
HEALTH LINE INTERNATIONAL CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
HERAEUS MEDICAL COMPONENTS, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
JOHNSON & JOHNSON PROFESSIONALS, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
KANEKA CORP
 
SUBSTANTIALLY EQUIVALENT
 1
KANEKA CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
MEDTRONIC INC.
 
SUBSTANTIALLY EQUIVALENT
 2
MEDTRONIC VASCULAR
 
SUBSTANTIALLY EQUIVALENT
 1
MEDTRONIC, INC
 
SUBSTANTIALLY EQUIVALENT
 1
MEDTRONIC, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
MERIT MEDICAL SYSTEMS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
 
SUBSTANTIALLY EQUIVALENT
 3
MICROVENTION, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
MIVI, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
NITILOOP LTD.
 
SUBSTANTIALLY EQUIVALENT
 3
PENUMBRA, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
QXMEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
REFLOW MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 3
ROXWOOD MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 6
SEQUENT MEDICAL, INC
 
SUBSTANTIALLY EQUIVALENT
 1
SEQUENT MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SILK ROAD MEDICAL, INC
 
SUBSTANTIALLY EQUIVALENT
 1
SPECTRANETICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ST. JUDE MEDICAL (ABBOTT LABORATORIES)
 
SUBSTANTIALLY EQUIVALENT
 1
ST. JUDE MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
STRYKER
 
SUBSTANTIALLY EQUIVALENT
 2
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 3
STRYKER NEUROVASCULAR
 
SUBSTANTIALLY EQUIVALENT
 2
SUREFIRE MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
SURMODICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
TERUMO CARDIOVASCULAR SYSTEMS
 
SUBSTANTIALLY EQUIVALENT
 1
TNI MANUFACTURING, INC
 
SUBSTANTIALLY EQUIVALENT
 2
VASCULAR SOLUTIONS, INC.
 
SUBSTANTIALLY EQUIVALENT
 7
Device Problems
Material Rupture
 1504
Break
 1163
Balloon
 867
Kinked
 857
Adverse Event Without Identified Device Or Use Problem
 658
Catheter
 556
Leak / Splash
 518
Detachment Of Device Or Device Component
 474
Retraction Problem
 445
Device Damaged Prior To Use
428
Material Deformation
 423
Physical Resistance
 396
Failure To Advance
 386
Detachment Of Device Component
 369
Material Separation
 344
Shaft
 327
Unraveled Material
 265
Deflation Problem
 248
Peeled / Delaminated
 218
Fracture
 199
Out-Of-Box Failure
 197
Crack
 170
Material Integrity Problem
 168
Material Frayed
 165
Difficult To Remove
159
Device Operates Differently Than Expected
 149
Mechanical Problem
 138
Difficult To Advance
 134
Burst Container Or Vessel
132
Entrapment Of Device
 126
Fluid Leak
 108
Device-Device Incompatibility
 108
Bent
 100
Physical Resistance / Sticking
 97
Hole In Material
 97
Inflation Problem
 89
Difficult To Insert
 88
Tip
 77
Connection Problem
 69
Device Damaged By Another Device
 67
Material Fragmentation
 63
Torn Material
 59
Device Contamination With Chemical Or Other Material
 57
Material Twisted / Bent
 54
Migration Or Expulsion Of Device
51
Partial Blockage
 45
Occlusion Within Device
 44
Material Puncture / Hole
 40
Split
 39
Stretched
 37
Device Handling Problem
 37
Device Markings / Labelling Problem
 36
Product Quality Problem
 33
Obstruction Of Flow
 32
Balloon Rupture
 30
Use Of Device Problem
 30
Air Leak
 30
Insufficient Information
 29
Mechanical Jam
 28
Defective Device
 26
Deformation Due To Compressive Stress
26
Appropriate Term/Code Not Available
 23
Material Split, Cut Or Torn
 22
Device Dislodged Or Dislocated
 19
Cut In Material
 19
Unsealed Device Packaging
 19
Sticking
 18
Accessory Incompatible
 17
Complete Blockage
 16
Human-Device Interface Problem
 16
Device Operational Issue
 15
Guidewire
 14
Defective Component
 14
Packaging Problem
 14
Separation Problem
14
Material Perforation
 13
Folded
 13
Tear, Rip Or Hole In Device Packaging
 13
Improper Or Incorrect Procedure Or Method
 13
Device Inoperable
 12
Loss Of Or Failure To Bond
 12
No Flow
 11
Compatibility Problem
 11
Positioning Problem
 11
Unable To Obtain Readings
11
Material Distortion
 10
Hub
 10
Collapse
 10
Gas Leak
 10
Patient-Device Incompatibility
 10
Delivered As Unsterile Product
 10
Overheating Of Device
 9
Device Expiration Issue
 9
Loose Or Intermittent Connection
 8
Positioning Failure
8
Fitting Problem
 8
Contamination During Use
 8
Infusion Or Flow Problem
 7
Component Missing
7
Reflux Within Device
 7
Total Device Problems 14400
Recalls
Manufacturer Recall Class Date Posted
1
Arrow International Inc
 II Jan-11-2019
2
Arrow International Inc
 II Jun-29-2018
3
Arrow International Inc
 II May-30-2018
4
Arrow International Inc
 II Apr-10-2018
5
Arrow International Inc
 II Feb-20-2018
6
Arrow International Inc
 II Jun-12-2017
7
Arrow International Inc
 II Oct-16-2014
8
Arrow International Inc
 II Oct-14-2014
9
Bard Access Systems
 II Mar-13-2015
10
Bard Peripheral Vascular Inc
 II May-11-2018
11
Bard Peripheral Vascular Inc
 II Apr-10-2015
12
Boston Scientific Corporation
 II Aug-08-2018
13
Boston Scientific Corporation
 II Jan-05-2016
14
Boston Scientific Corporation
 II Jun-25-2015
15
Boston Scientific Corporation
 II Mar-10-2014
16
Concentric Medical Inc
 II Oct-09-2015
17
Concentric Medical Inc
 II Dec-12-2014
18
Cook Inc.
 II Apr-25-2018
19
Cook Inc.
 II Mar-09-2018
20
Cook Inc.
 II Aug-22-2016
21
Cook Inc.
 I Feb-24-2016
22
Ev3, Inc.
 II Apr-23-2014
23
Medtronic Inc
 I Mar-29-2018
24
Medtronic Vascular
 II Jun-26-2015
25
Medtronic Vascular
 II Nov-13-2014
26
Medtronic Vascular, Inc.
 II Nov-06-2015
27
Micro Therapeutics Inc, Dba Ev3 Neurovascular
 I Nov-09-2016
28
Micro Therapeutics Inc, Dba Ev3 Neurovascular
 I Apr-16-2014
29
ReFlow Medical
 I Mar-29-2017
30
SPS Sterilization, Inc
 II Sep-13-2018
31
Stryker Neurovascular
 II Sep-28-2018
32
Stryker Neurovascular
 II Jul-28-2018
33
Stryker Neurovascular
 II Nov-02-2016
34
Vascular Solutions, Inc.
 I May-22-2017
35
Vascular Solutions, Inc.
 I Oct-20-2016
TPLC Last Update: 2019-04-02 19:40:23
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