Catheter, Continuous Flush

Device Code: 848

Product Code(s): KRA

Device Classification Information

Device Type ID	848
Device Name	Catheter, Continuous Flush
Regulation Description	Continuous Flush Catheter.
Regulation Medical Specialty	Cardiovascular
Review Panel	Cardiovascular
Premarket Review	Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB)
Submission Type	510(k)
CFR Regulation Number	870.1210 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	KRA
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID	848
Device	Catheter, Continuous Flush
Product Code	KRA
FDA Device Classification	Class 2 Medical Device
Regulation Description	Continuous Flush Catheter.
CFR Regulation Number	870.1210 [🔎]

Premarket Reviews
Manufacturer	Decision
ABLATIVE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	3
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
BTG INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	4
EDWARDS LIFESCIENCES
	SUBSTANTIALLY EQUIVALENT	4
EDWARDS LIFESCIENCES LLC
	SUBSTANTIALLY EQUIVALENT	2
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	2
MERCATOR MEDSYSTEMS,
	SUBSTANTIALLY EQUIVALENT	2
MERCATOR MEDSYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	3
REX MEDICAL, L.P.
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR INSIGHTS LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Catheter	370
Break	331
Adverse Event Without Identified Device Or Use Problem	146
Physical Resistance	120
Fracture	94
Material Separation	89
Aspiration Issue	82
Device Displays Incorrect Message	71
Difficult To Remove	65
Burst Container Or Vessel	57
Device Dislodged Or Dislocated	48
Detachment Of Device Component	47
Leak / Splash	43
Obstruction Of Flow	43
Device Damaged Prior To Use	41
Shaft	40
Entrapment Of Device	36
Physical Resistance / Sticking	34
Device Damaged By Another Device	33
Balloon	33
Tip	32
Kinked	31
Detachment Of Device Or Device Component	29
Fitting Problem	29
Material Integrity Problem	25
Material Deformation	24
Material Rupture	21
Difficult To Advance	19
Peeled / Delaminated	16
Hole In Material	16
Inflation Problem	16
Guidewire	15
Occlusion Within Device	15
Device Operates Differently Than Expected	13
Material Perforation	13
Material Fragmentation	12
Device Handling Problem	12
Device Inoperable	12
Material Puncture / Hole	12
Deformation Due To Compressive Stress	11
Device Contamination With Chemical Or Other Material	11
Fluid Leak	11
Delamination	10
Appropriate Term/Code Not Available	9
Deflation Problem	7
Failure To Advance	7
Torn Material	7
Difficult To Insert	7
Flaked	7
Hub	7
Electrical Shorting	6
Positioning Problem	5
Difficult To Open Or Remove Packaging Material	5
Mechanical Problem	5
Stretched	5
Device Or Device Fragments Location Unknown	5
Crack	4
Partial Blockage	4
Device Packaging Compromised	4
Bent	4
Failure To Prime	3
Tear, Rip Or Hole In Device Packaging	3
Use Of Device Problem	3
No Flow	3
Contamination / Decontamination Problem	3
Split	3
Insufficient Information	3
Radiation Underexposure	3
Disconnection	3
Restricted Flow Rate	2
Device Markings / Labelling Problem	2
Improper Flow Or Infusion	2
Cut In Material	2
Incorrect, Inadequate Or Imprecise Result Or Readings	2
Difficult To Position	2
Device Issue	2
Complete Blockage	2
Positioning Failure	2
Coil	2
Unraveled Material	2
Wire	2
Material Frayed	2
No Apparent Adverse Event	2
Component Missing	2
Incorrect Measurement	2
Device Difficult To Setup Or Prepare	2
Port	2
Device Stops Intermittently	2
Tip Breakage	2
Material Twisted / Bent	2
Migration Or Expulsion Of Device	2
Uncoiled	1
Patient-Device Incompatibility	1
Product Quality Problem	1
Compatibility Problem	1
Loss Of Or Failure To Bond	1
Smoking	1
Melted	1
Difficult To Flush	1
Failure To Deliver	1
Total Device Problems	2406

Recalls
Manufacturer		Recall Class	Date Posted
1	Angiodynamics, Inc.	II	Aug-18-2014
2	Cook Inc.	II	Mar-02-2017
3	Cook Inc.	II	Nov-06-2015
4	Covidien	I	Feb-03-2015
5	EKOS Corporation	II	Sep-21-2016
6	EKOS Corporation	II	Feb-24-2016
7	EKOS Corporation	II	Jul-20-2015
8	Medtronic Inc. Cardiac Rhythm Disease Management	II	Apr-02-2015
9	Merit Medical Systems, Inc.	II	Oct-31-2014
10	Micro Therapeutics Inc, Dba Ev3 Neurovascular	I	Nov-09-2016
11	Sequent Medical Inc	II	Oct-27-2016
12	Vascular Insights, LLC	II	Mar-21-2018

TPLC Last Update: 2019-04-02 19:43:23