Catheter, Angioplasty, Peripheral, Transluminal

Device Code: 863

Product Code(s): LIT

Device Classification Information

• Device Type ID: 863
• Device Name: Catheter, Angioplasty, Peripheral, Transluminal
• Regulation Description: Percutaneous Catheter.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Peripheral Interventional Devices Branch (PIDB)
• Submission Type: 510(k)
• CFR Regulation Number: 870.1250 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LIT
• 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

• 6-301 ISO 10555-1 Second Edition 2013-06-15
  Intravascular Catheters - Sterile And Single-use Intravascular Catheters - Part 1: General Requirements
• 6-322 ISO 10555-4 Second Edition 2013-06-15
  Intravascular Catheters -- Sterile And Single-use Catheters -- Part 4: Balloon Dilatation Catheters
• 6-408 ISO 10555-1 Second Edition 2013-06-15
  Intravascular Catheters - Sterile And Single-use Intravascular Catheters - Part 1: General Requirements [Including AMENDMENT 1 (2017)]

Total Product Life Cycle

• Device Type ID: 863
• Device: Catheter, Angioplasty, Peripheral, Transluminal
• Product Code: LIT
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Percutaneous Catheter.
• CFR Regulation Number: 870.1250 [🔎]

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	1
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
ARRAVASC LIMITED
	SUBSTANTIALLY EQUIVALENT	2
BIOTRONIK GMBG & CO.
	SUBSTANTIALLY EQUIVALENT	3
BIOTRONIK, INC.
	SUBSTANTIALLY EQUIVALENT	3
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	7
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
C. R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	2
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	2
CONTEGO MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	1
CORDIS CORP.
	SUBSTANTIALLY EQUIVALENT	1
CORDIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN LLC
	SUBSTANTIALLY EQUIVALENT	1
EV3 CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
KANEKA CORP
	SUBSTANTIALLY EQUIVALENT	6
KANEKA CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NATEC MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	3
NIPRO CORP
	SUBSTANTIALLY EQUIVALENT	1
NIPRO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
O'CONNELL REGULATORY CONSULTANTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
OSTIAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Balloon	2888
Material Rupture	2282
Burst Container Or Vessel	1303
Leak / Splash	368
Adverse Event Without Identified Device Or Use Problem	360
Detachment Of Device Or Device Component	287
Catheter	281
Difficult To Remove	236
Deflation Problem	227
Break	202
Detachment Of Device Component	157
Retraction Problem	157
Inflation Problem	101
Shaft	90
Material Separation	83
Entrapment Of Device	83
Failure To Advance	79
Material Deformation	70
Cutter	55
Tip	46
Difficult To Advance	44
Material Frayed	43
Hole In Material	40
Improper Or Incorrect Procedure Or Method	37
Peeled / Delaminated	32
Device Handling Problem	28
Torn Material	26
Material Puncture / Hole	23
Device Dislodged Or Dislocated	21
Device Contamination With Chemical Or Other Material	21
Defective Device	20
Crack	18
Use Of Device Problem	18
Fracture	17
Packaging Problem	17
Device Markings / Labelling Problem	17
Device-Device Incompatibility	16
Off-Label Use	16
Kinked	15
Device Damaged Prior To Use	15
Fluid Leak	15
Difficult To Insert	14
Structural Problem	13
Material Split, Cut Or Torn	12
Device Damaged By Another Device	12
Unraveled Material	11
Material Integrity Problem	10
Difficult To Position	10
Material Twisted / Bent	9
Device Operates Differently Than Expected	8
Unsealed Device Packaging	8
Material Fragmentation	7
Bent	7
Physical Resistance	7
Tear, Rip Or Hole In Device Packaging	6
Balloon Rupture	6
Component Missing	5
Failure To Fold	5
Partial Blockage	5
Indicator	5
Device Expiration Issue	4
Device Packaging Compromised	4
Occlusion Within Device	4
Deformation Due To Compressive Stress	4
Stent	3
Appropriate Term/Code Not Available	3
Delivered As Unsterile Product	3
Physical Resistance / Sticking	3
Shelf Life Exceeded	3
Stretched	3
Hub	3
Device Disinfection Or Sterilization Issue	2
Material Perforation	2
Filter	2
Display	2
Sticking	2
Folded	2
Wire	2
Contamination / Decontamination Problem	2
Connection Problem	2
Activation Failure Including Expansion Failures	2
Activation, Positioning Or Separation Problem	2
Defective Component	2
Contamination During Use	2
Product Quality Problem	1
Y-Piece Connector	1
Implant Mobility NOS (Not Otherwise Specified)	1
Patient-Device Incompatibility	1
Calcified	1
No Apparent Adverse Event	1
Obstruction Of Flow	1
Balloon Burst	1
Loss Of Or Failure To Bond	1
Incorrect Measurement	1
Device Difficult To Setup Or Prepare	1
Protector	1
Coiled	1
Unintended System Motion	1
Air Leak	1
Wire(s), Breakage Of	1
Total Device Problems	10093

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Feb-11-2014
2	BrosMed Medical Co.,Ltd.	II	Feb-27-2019
3	Cordis Corporation	II	Nov-06-2018
4	Cordis Corporation	II	Jan-16-2015
5	EXP Pharmaceutical Services Corp	II	Jul-24-2015
6	Medtronic Inc	II	Dec-22-2016
7	Us Endovascular	II	Apr-11-2016
8	ev3, Inc.	II	Apr-22-2016

TPLC Last Update: 2019-04-02 19:43:45