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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, thrombus retriever
Regulation Description Percutaneous catheter.
Definition The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
Product CodeNRY
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 16
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 11

Device Problems
No Known Device Problem 376
Kinked 92
Out-of-box failure 88
Break 78
Device damaged prior to use 73
Fracture 49
Physical resistance 36
Difficult to remove 30
Stretched 16
Aspiration issue 16
Material separation 14
Crack 12
Difficult to advance 11
Device handling issue 10
Material deformation 8
Device operates differently than expected 8
Failure to advance 8
Retraction problem 8
Sticking 8
Unraveled material 7
Material integrity issue 7
Detachment of device or device component 6
Entrapment of device or device component 6
Difficult to insert 6
Bent 5
Detachment of device component 4
No Information 4
Material fragmentation 3
Leak 3
Flaked 3
Fluid leak 2
Collapse 2
Hole in material 2
Device, or device fragments remain in patient 2
Defective component 2
Component missing 2
Improper or incorrect procedure or method 2
Suction issue 2
Migration of device or device component 2
Occlusion within device 2
Mechanical jam 2
No Pressure 2
Buckled material 2
Defective item 2
Malfunction 2
Cut in material 1
Tear, rip or hole in device packaging 1
Device or device fragments location unknown 1
Patient-device incompatibility 1
Connection issue 1
Device or device component damaged by another device 1
Device packaging compromised 1
Human-Device Interface Issue 1
Therapeutic or diagnostic output failure 1
Not Applicable 1
No flow 1
Material twisted 1
Noise, Audible 1
Difficult to position 1
Misconnection 1
Shaft break 1
Use of Device Issue 1
Mechanical issue 1
Knotted 1
Air leak 1
Total Device Problems 1045

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 2 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Concentric Medical Inc II Dec-08-2014
2 Concentric Medical Inc II Sep-08-2014
3 Penumbra Inc. I Nov-24-2010

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