Filter, Intravascular, Cardiovascular

Device Code: 788

Product Code(s): DTK

Device Classification Information

• Device Type ID: 788
• Device Name: Filter, Intravascular, Cardiovascular
• Regulation Description: Cardiovascular Intravascular Filter.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Vascular Surgery Devices Branch (VSDB)
• Submission Type: 510(k)
• CFR Regulation Number: 870.3375 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DTK
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 3-103 ISO 25539-3 First Edition 2011-12-01
  Cardiovascular Implants - Endovascular Devices - Part 3: Vena Cava Filters
• 3-104 ASTM F2914-12
  Standard Guide For Identification Of Shelf-life Test Attributes For Endovascular Devices

Total Product Life Cycle

• Device Type ID: 788
• Device: Filter, Intravascular, Cardiovascular
• Product Code: DTK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Cardiovascular Intravascular Filter.
• CFR Regulation Number: 870.3375 [🔎]

Premarket Reviews
Manufacturer	Decision
ALN IMPLANTS CHIRURGICAUX
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	2
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	1
CORDIS, A JOHNSON & JOHNSON CO.
	SUBSTANTIALLY EQUIVALENT	1
VOLCANO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WILLIAM COOK
	SUBSTANTIALLY EQUIVALENT	3
WILLIAM COOK EUROPE APS
	SUBSTANTIALLY EQUIVALENT	3

Device Problems
Insufficient Information	4604
Difficult To Remove	3646
Appropriate Term/Code Not Available	1862
Unintended Movement	1740
Malposition Of Device	1349
Filter	1299
Migration Or Expulsion Of Device	1245
Adverse Event Without Identified Device Or Use Problem	1178
Fracture	857
Detachment Of Device Or Device Component	661
Extrusion	583
Failure To Align	535
Patient Device Interaction Problem	401
Failure To Advance	271
Activation Failure Including Expansion Failures	180
Occlusion Within Device	160
Activation, Positioning Or Separation Problem	154
Difficult Or Delayed Positioning	94
Entrapment Of Device	87
Material Separation	86
Positioning Failure	76
Kinked	73
Material Deformation	68
Detachment Of Device Component	62
Premature Activation	54
Migration	52
Difficult To Advance	47
Bent	42
Obstruction Of Flow	42
Material Perforation	41
Break	41
Material Puncture / Hole	40
Device Dislodged Or Dislocated	33
Complete Blockage	32
Positioning Problem	29
Device Handling Problem	23
Material Twisted / Bent	21
Difficult To Insert	19
Retraction Problem	18
Device Operates Differently Than Expected	17
Catheter	16
Material Frayed	16
Material Fragmentation	13
Tip	12
Therapy Delivered To Incorrect Body Area	11
Material Erosion	10
Failure To Unfold Or Unwrap	10
Device Or Device Fragments Location Unknown	10
Torn Material	9
Filtration Problem	9
Other (for Use When An Appropriate Device Code Cannot Be Identified)	9
Device Difficult To Setup Or Prepare	9
Device Issue	8
Leak / Splash	7
Stent	7
Improper Or Incorrect Procedure Or Method	7
Use Of Device Problem	6
Difficult To Position	6
Split	6
Sticking	5
Deformation Due To Compressive Stress	5
Difficult To Open Or Close	5
Defective Component	5
Physical Resistance	5
Failure To Capture	4
Material Split, Cut Or Torn	4
Cannula Guide	4
Partial Blockage	4
Device Contamination With Chemical Or Other Material	4
Material Protrusion / Extrusion	4
Component Or Accessory Incompatibility	4
Expulsion	4
Packaging Problem	4
Crack	4
Difficult Or Delayed Activation	4
Material Distortion	3
Device Markings / Labelling Problem	3
Material Rupture	3
Mechanical Problem	3
Collapse	3
Inadequate User Interface	3
Unsealed Device Packaging	3
Difficult To Flush	3
Strut Fracture	3
Delivered As Unsterile Product	3
Failure To Adhere Or Bond	3
Patient-Device Incompatibility	3
Device Operational Issue	3
Tear, Rip Or Hole In Device Packaging	2
Shaft	2
Unknown (for Use When The Device Problem Is Not Known)	2
Component Missing	2
No Apparent Adverse Event	2
Separation Failure	2
Hole In Material	2
Device Subassembly	2
Fitting Problem	2
Dent In Material	2
Defective Device	2
Cut In Material	2
Total Device Problems	22135

Recalls
Manufacturer		Recall Class	Date Posted
1	Bard Peripheral Vascular Inc	II	Mar-08-2016
2	Bard Peripheral Vascular Inc	II	Feb-01-2016
3	Cook Medical Incorporated	III	Mar-19-2019

TPLC Last Update: 2019-04-02 19:41:33