Dilator, Vessel, For Percutaneous Catheterization

Device Code: 745

Product Code(s): DRE

Device Type ID	745
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Regulation Description	Vessel Dilator For Percutaneous Catheterization.
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	870.1310 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	DRE
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Expansion Pilot Program

Device Type ID	745
Device	Dilator, Vessel, For Percutaneous Catheterization
Product Code	DRE
FDA Device Classification	Class 2 Medical Device
Regulation Description	Vessel Dilator For Percutaneous Catheterization.
CFR Regulation Number	870.1310 [🔎]

Premarket Reviews
Manufacturer	Decision
ARSTASIS
	SUBSTANTIALLY EQUIVALENT	1
ARSTASIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAYLIS MEDICAL COMPANY INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOTEQUE CORP
	SUBSTANTIALLY EQUIVALENT	1
CARDIAC ASSIST DIV.
	SUBSTANTIALLY EQUIVALENT	1
COOK VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	2
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	4
GALT MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT - KIT	1
SPECTRANETICS CORP.
	SUBSTANTIALLY EQUIVALENT	2
SPECTRANETICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SPECTRANETICS, INC.
	SUBSTANTIALLY EQUIVALENT	4
THERAGENICS CORP.
	SUBSTANTIALLY EQUIVALENT - KIT	1
TOGO MEDIKIT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Adverse Event Without Identified Device Or Use Problem	78
Catheter	55
Fracture	53
Material Separation	49
Detachment Of Device Component	23
Device Contamination With Chemical Or Other Material	18
Break	18
Difficult To Remove	15
Appropriate Term/Code Not Available	12
Tip	10
Difficult To Insert	10
Crack	8
Stretched	7
Torn Material	7
Material Fragmentation	6
Material Deformation	5
Physical Resistance / Sticking	5
Packaging Problem	5
Deformation Due To Compressive Stress	5
Migration Or Expulsion Of Device	5
Port	4
Hemo Valve	4
Material Frayed	4
Other (for Use When An Appropriate Device Code Cannot Be Identified)	4
Cut In Material	4
Split	4
Sharp Edges	4
Flaked	3
Detachment Of Device Or Device Component	3
Failure To Align	3
Noise, Audible	3
Mechanical Jam	3
Device Operates Differently Than Expected	3
Tip Breakage	2
Material Integrity Problem	2
Activation, Positioning Or Separation Problem	2
Material Puncture / Hole	2
Unsealed Device Packaging	2
Difficult To Advance	2
Scratched Material	1
Hub	1
Separation Problem	1
Difficult To Open Or Remove Packaging Material	1
Naturally Worn	1
Wire(s), Breakage Of	1
Separation Failure	1
Device Damaged By Another Device	1
Cannula Guide	1
Lead(s), Breakage Of	1
Leak / Splash	1
Peeled / Delaminated	1
Retraction Problem	1
Use Of Device Problem	1
Stent	1
Cannula, Inner	1
Difficult To Flush	1
Device Dislodged Or Dislocated	1
Membrane Tear(s)	1
Delivered As Unsterile Product	1
Unraveled Material	1
Cannula	1
Migration	1
Uncoiled	1
Total Device Problems	476

TPLC Last Update: 2019-04-02 19:40:27