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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 328
Break 73
Kinked 71
Out-of-box failure 68
Device damaged prior to use 54
Fracture 44
Difficult to remove 27
Physical resistance 26
Material separation 14
Stretched 14
Aspiration issue 12
Difficult to advance 9
Sticking 8
Crack 8
Unraveled material 7
Device handling issue 7
Device operates differently than expected 6
Failure to advance 6
Retraction problem 6
Difficult to insert 6
Entrapment of device or device component 5
Material deformation 5
Material integrity issue 5
Detachment of device or device component 4
No Information 4
Bent 4
Detachment of device component 4
Material fragmentation 3
Leak 3
Flaked 3
Fluid leak 2
Hole in material 2
Migration of device or device component 2
Occlusion within device 2
Device, or device fragments remain in patient 2
Improper or incorrect procedure or method 2
Suction issue 2
Defective component 2
Component missing 2
No Pressure 2
Buckled material 2
Defective item 2
Malfunction 2
Mechanical jam 2
No flow 1
Material twisted 1
Device or device component damaged by another device 1
Device packaging compromised 1
Human-Device Interface Issue 1
Cut in material 1
Device or device fragments location unknown 1
Connection issue 1
Therapeutic or diagnostic output failure 1
Not Applicable 1
Noise, Audible 1
Tear, rip or hole in device packaging 1
Use of Device Issue 1
Shaft break 1
Difficult to position 1
Mechanical issue 1
Knotted 1
Air leak 1
Collapse 1
Total Device Problems 881

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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