Set, Administration, Intravascular

Device Code: 2579

Product Code(s): FPA

Device Classification Information

Device Type ID2579
Device NameSet, Administration, Intravascular
Regulation DescriptionIntravascular Administration Set.
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 Number880.5440 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeFPA
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID2579
DeviceSet, Administration, Intravascular
Product CodeFPA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionIntravascular Administration Set.
CFR Regulation Number880.5440 [🔎]
Premarket Reviews
ManufacturerDecision
ACACIA, INC.
 
SUBSTANTIALLY EQUIVALENT
1
AMSINO INTERNATIONAL, INC.
 
SUBSTANTIALLY EQUIVALENT
1
ATRION CORP.
 
SUBSTANTIALLY EQUIVALENT
3
B. BRAUN MEDICAL INC.
 
SUBSTANTIALLY EQUIVALENT
6
B. BRAUN MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
7
BAXTER HEALTHCARE CORP.
 
SUBSTANTIALLY EQUIVALENT
7
BAXTER HEALTHCARE CORPORATION
 
SUBSTANTIALLY EQUIVALENT
7
BD
 
SUBSTANTIALLY EQUIVALENT
4
BECTON, DICKINSON & CO.
 
SUBSTANTIALLY EQUIVALENT
3
BECTON, DICKINSON AND COMPANY
 
SUBSTANTIALLY EQUIVALENT
3
BIOMEDIX
 
SUBSTANTIALLY EQUIVALENT
1
BUSSE HOSPITAL DISPOSABLES
 
SUBSTANTIALLY EQUIVALENT
1
BUSSE HOSPITAL DISPOSABLES, INC.
 
SUBSTANTIALLY EQUIVALENT
1
CAIR LGL
 
SUBSTANTIALLY EQUIVALENT
2
CAREFUSION
 
SUBSTANTIALLY EQUIVALENT
2
CONVATEC INC.
 
SUBSTANTIALLY EQUIVALENT
3
DELTA MED SPA
 
SUBSTANTIALLY EQUIVALENT
1
EMED TECHNOLOGIES CORPORATION
 
SUBSTANTIALLY EQUIVALENT
2
HOSPIRA INC.
 
SUBSTANTIALLY EQUIVALENT
1
HOSPIRA, INC
 
SUBSTANTIALLY EQUIVALENT
1
HOSPIRA, INC.
 
SUBSTANTIALLY EQUIVALENT
9
IMED TECHNOLOGY, INC.
 
SUBSTANTIALLY EQUIVALENT
1
JIANGYIN CAINA TECHNOLOGY CO., LTD
 
SUBSTANTIALLY EQUIVALENT
1
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
 
SUBSTANTIALLY EQUIVALENT
1
MEDLINE
 
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
 
SUBSTANTIALLY EQUIVALENT
1
NEXUS MEDICAL LLC
 
SUBSTANTIALLY EQUIVALENT
1
NEXUS MEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
1
PADI-LOCK, LLC
 
SUBSTANTIALLY EQUIVALENT
1
PFIZER
 
SUBSTANTIALLY EQUIVALENT
8
Q CORE MEDICAL LTD
 
SUBSTANTIALLY EQUIVALENT
1
QUEST MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
3
ROCHE DIAGNOSTICS CORP.
 
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS GMBH
 
SUBSTANTIALLY EQUIVALENT
1
RYMED TECHNOLOGIES, LLC
 
SUBSTANTIALLY EQUIVALENT
1
SHINVA ANDE HEALTHCARE APPARATUS CO.,LTD.
 
SUBSTANTIALLY EQUIVALENT
1
TERUMO CARDIOVASCULAR SYSTEMS
 
SUBSTANTIALLY EQUIVALENT
2
TERUMO EUROPE N.V.
 
SUBSTANTIALLY EQUIVALENT
2
TEVA MEDICAL, LTD. (MIGADA PLANT)
 
SUBSTANTIALLY EQUIVALENT
1
TOPSPINS, INC.
 
SUBSTANTIALLY EQUIVALENT
1
UNOMEDICAL
 
SUBSTANTIALLY EQUIVALENT
3
VELANO VASCULAR
 
SUBSTANTIALLY EQUIVALENT
1
WAI MEDICAL TECHNOLOGIES LLC
 
SUBSTANTIALLY EQUIVALENT
1
YPSOMED AG
 
SUBSTANTIALLY EQUIVALENT
1
ZYNO MEDICAL LLC
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
Fluid Leak
8936
Leak / Splash
2468
Tube
1932
Disconnection
1627
Break
1266
Crack
1067
Material Separation
1067
Failure To Adhere Or Bond
1067
Detachment Of Device Or Device Component
1001
Connector
853
Cannula
779
Device Operates Differently Than Expected
768
No Flow
656
Reflux Within Device
630
Adhesive
617
Detachment Of Device Component
551
Failure To Prime
529
Material Deformation
435
Luer Valve
400
Bent
379
Air Eliminator
369
Infusion Or Flow Problem
351
Adverse Event Without Identified Device Or Use Problem
306
Hole In Material
306
Filter
305
Connection Problem
296
Occlusion Within Device
283
Valve
251
Kinked
247
Port
229
Loss Of Or Failure To Bond
206
Insufficient Flow Or Under Infusion
193
Failure To Infuse
188
Partial Blockage
179
Improper Flow Or Infusion
172
Device Contamination With Chemical Or Other Material
161
Filling Problem
153
Device Alarm System
142
Material Fragmentation
137
Y-Piece Connector
135
Needle
134
Excess Flow Or Over-Infusion
127
Sticking
121
Adapter (Adaptor)
116
Material Integrity Problem
113
Pump
112
Cap
107
Headset
106
System
105
Material Rupture
104
Loose Or Intermittent Connection
102
Cut In Material
100
Free Or Unrestricted Flow
98
Device Displays Incorrect Message
96
Deformation Due To Compressive Stress
94
Insufficient Information
94
Device Dislodged Or Dislocated
93
Material Twisted / Bent
92
Component Missing
91
Device Component Or Accessory
87
Improper Or Incorrect Procedure Or Method
86
Protective Measures Problem
77
Fitting Problem
77
Mechanical Problem
76
Failure To Disconnect
76
Cassette
74
Fracture
73
Material Puncture / Hole
73
Obstruction Of Flow
60
Defective Device
55
Packaging Problem
55
Difficult Or Delayed Activation
54
Clamp
54
Device Operational Issue
52
Separation Failure
49
One-Way Valve
46
Appropriate Term/Code Not Available
44
Product Quality Problem
43
Air Leak
41
Stretched
41
Manufacturing, Packaging Or Shipping Problem
39
T-Piece Connector
37
No Apparent Adverse Event
37
Material Split, Cut Or Torn
36
Component(s), Broken
34
Physical Resistance / Sticking
32
Backflow
32
Migration Or Expulsion Of Device
31
Failure To Reset
30
Catheter
30
Regulator
30
Failure To Advance
29
Device Slipped
27
Torn Material
27
Tear, Rip Or Hole In Device Packaging
26
Burst Container Or Vessel
25
Use Of Device Problem
25
Melted
24
Material Distortion
24
Volume Accuracy Problem
24
Total Device Problems 35534
Recalls
Manufacturer Recall Class Date Posted
1
Angiodynamics Inc. (Navilyst Medical Inc.)
II Mar-29-2017
2
B Braun Medical Inc
II May-23-2017
3
B. Braun Medical, Inc.
II Jun-25-2018
4
B. Braun Medical, Inc.
II Jul-09-2014
5
B. Braun Medical, Inc.
II Feb-18-2014
6
Bard Access Systems
II Jan-10-2017
7
Bard Access Systems
II Apr-30-2015
8
Bard Access Systems
II Mar-13-2015
9
Baxter Healthcare Corp
II Oct-16-2015
10
Baxter Healthcare Corp
II Sep-09-2014
11
Baxter Healthcare Corp.
II Aug-29-2016
12
Baxter Healthcare Corp.
II Jan-07-2016
13
Bayer Medical Care, Inc.
II Oct-11-2018
14
Becton Dickinson & Company
II Nov-04-2018
15
Becton Dickinson & Company
II May-01-2017
16
Becton Dickinson & Company
II Mar-25-2015
17
Biomedix, Inc.
II Oct-06-2014
18
CareFusion 303, Inc.
II Nov-04-2018
19
CareFusion 303, Inc.
II Jun-07-2018
20
CareFusion 303, Inc.
II Aug-11-2017
21
CareFusion 303, Inc.
II Apr-27-2017
22
CareFusion 303, Inc.
II Feb-28-2017
23
CareFusion 303, Inc.
II Feb-28-2017
24
CareFusion 303, Inc.
II Mar-17-2016
25
CareFusion 303, Inc.
II Dec-17-2015
26
CareFusion 303, Inc.
II Nov-05-2015
27
CareFusion 303, Inc.
II Feb-04-2015
28
CareFusion 303, Inc.
II Jul-09-2014
29
CareFusion 303, Inc.
II Apr-16-2014
30
CareFusion 303, Inc.
II Feb-04-2014
31
CareFusion 303, Inc.
II Feb-03-2014
32
Centurion Medical Products Corporation
II Feb-23-2016
33
Churchill Medical Systems, Inc.
II Apr-21-2015
34
Churchill Medical Systems, Inc.
II Jan-23-2014
35
Codan Us Corporation
II Jul-10-2014
36
ConMed Corporation
II Feb-28-2018
37
Global Healthcare Inc
II Feb-03-2016
38
Hospira Inc.
II Jun-29-2016
39
Hospira Inc.
II Mar-06-2014
40
ICU Medical, Inc.
II Jan-10-2017
41
ICU Medical, Inc.
II Jan-09-2014
42
Medtronic Inc.
II Jul-05-2018
43
Medtronic Inc.
II Nov-18-2017
44
Medtronic MiniMed Inc.
II Dec-12-2014
45
Merit Medical Systems, Inc.
II Nov-21-2016
46
Navilyst Medical, Inc.
II Jan-24-2014
47
RGI Medical Manufacturing, Inc.
II Jul-07-2014
48
Repro-Med Systems, Inc.
II Jan-05-2018
49
Roche Diagnostics Operations, Inc.
II Dec-30-2014
50
Rymed Technologies, LLC
II Jan-21-2016
51
Smiths Medical ASD Inc.
II Oct-11-2018
52
Smiths Medical ASD Inc.
II Jul-24-2017
53
Smiths Medical ASD Inc.
II Mar-30-2017
54
Smiths Medical ASD, Inc.
II May-27-2016
55
Smiths Medical ASD, Inc.
II Mar-17-2015
56
Smiths Medical Asd Inc
II Jun-08-2015
57
US Infusion Inc Dba Trucare Biomedix-USA
II Mar-13-2015
58
Unomedical As
II Nov-03-2016
59
Unomedical As
II Jun-19-2015
60
Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc.
II Feb-21-2018
61
Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc.
II Mar-18-2017
62
Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc.
II Dec-18-2016
63
WalkMed Infusion, LLC
II Jul-18-2016
64
Zevex Incorporated (dba Moog Medical Medical Devices Group)
II Feb-23-2018
65
Zyno Medical LLC
II Sep-27-2016
TPLC Last Update: 2019-04-02 20:15:13

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