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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device syringe, balloon inflation
Regulation Description Angiographic injector and syringe.
Product CodeMAV
Regulation Number 870.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 3
ANGEION CORP.
  SUBSTANTIALLY EQUIVALENT 1
ATRION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 4
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 6
NAMIC
  SUBSTANTIALLY EQUIVALENT 1
SCIMED
  SUBSTANTIALLY EQUIVALENT 3
SEDAT
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1

Device Problems
Incorrect measurement 55
Unable to obtain readings 54
Incorrect display 43
Inflation issue 38
Deflation issue 34
Other (for use when an appropriate device code cannot be identified) 27
Break 14
Leak 13
No display or display failure 13
No code available 11
Device operates differently than expected 10
Foreign material present in device 10
Detachment of device component 10
Mislabeled 9
Defective item 8
Foreign material 7
Unknown (for use when the device problem is not known) 6
Device damaged prior to use 5
Contamination during use 4
Crack 4
Measurements, inaccurate 4
Bubble(s) 3
Failure to zero 3
Pressure issue 3
No Information 3
Detachment of device or device component 2
Device Contamination with biological material 2
Sticking 2
Unstable 2
Unsealed device packaging 2
Defective component 2
Device Issue 2
Malfunction 2
High Readings 2
Low readings 2
Air leak 2
Balloon rupture 2
Fracture 2
Hole in material 1
False reading from device non-compliance 1
No device output 1
Device maintenance issue 1
Component(s), broken 1
Display misread 1
Erratic display 1
Meter failure 1
Tear, rip or hole in device packaging 1
Seal, defective 1
Material perforation 1
Pressure sensor failure 1
Decrease in pressure 1
Material rupture 1
Material separation 1
Use of Device Issue 1
Device markings issue 1
Item contaminated during manufacturing or shipping 1
No Known Device Problem 1
Packaging issue 1
Difficult to open or close 1
Total Device Problems 438

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

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Vascular III Feb-26-2014
2 Medtronic, Inc. II Aug-25-2010
3 PEROUSE MEDICAL II Dec-29-2014
4 Perouse Medical II Jul-22-2014

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