Set, Administration, Intravascular

Device Code: 2579

Product Code(s): FPA

Device Classification Information

Device Type ID	2579
Device Name	Set, Administration, Intravascular
Regulation Description	Intravascular Administration Set.
Regulation Medical Specialty	General Hospital
Review Panel	General 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 Type	510(k)
CFR Regulation Number	880.5440 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	FPA
GMP Exempt	No
Summary MR	Ineligible
Implanted Device	No
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Program

Recognized Standards

5-108 ISO 80369-6 First Edition 2016-03-15
Small Bore Connectors For Liquids And Gases In Healthcare Applications - Part 6: Connectors For Neuraxial Applications.
6-122 ISO 8536-5 Second Edition 2004-02-01
Infusion Equipment For Medical Use - Part 5: Burette Infusion Sets For Single Use, Gravity Feed
6-273 ISO 23908 First Edition 2011-06-11
Sharps Injury Protection - Requirements And Test Methods - Sharps Protection Features For Single-use Hypodermic Needles, Introducers For Catheters And Needles Used For Blood Sampling
6-318 ISO 8536-4 Fifth Edition 2010-10-01
Infusion Equipment For Medical Use - Part 4: Infusion Sets For Single Use, Gravity Feed [Including: Amendment 1 (2013)]
6-359 ISO 8536-9 Second Edition 2015-06-15
Infusion Equipment For Medical Use - Part 9: Fluid Lines For Single Use With Pressure Infusion Equipment
6-360 ISO 8536-10 Second Edition 2015-06-15
Infusion Equipment For Medical Use - Part 10: Accessories For Fluid Lines For Single Use With Pressure Infusion Equipment
6-361 ISO 8536-11 Second Edition 2015-06-15
Infusion Equipment For Medical Use - Part 11: Infusion Filters For Single Use With Pressure Infusion Equipment

Total Product Life Cycle

Device Type ID	2579
Device	Set, Administration, Intravascular
Product Code	FPA
FDA Device Classification	Class 2 Medical Device
Regulation Description	Intravascular Administration Set.
CFR Regulation Number	880.5440 [🔎]

Premarket Reviews
Manufacturer	Decision
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