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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 3
  SUBSTANTIALLY EQUIVALENT - KIT 1
ANGEION CORP.
  SUBSTANTIALLY EQUIVALENT 1
ATRION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
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

Device Problems
Unable to obtain readings 51
Deflation issue 34
Inflation issue 33
Other (for use when an appropriate device code cannot be identified) 27
Incorrect display 23
Incorrect measurement 22
No display or display failure 13
No code available 11
Mislabeled 9
Defective item 8
Foreign material 7
Detachment of device component 7
Break 7
Leak 7
Unknown (for use when the device problem is not known) 6
Measurements, inaccurate 4
Foreign material present in device 4
No Information 3
Bubble(s) 3
Contamination during use 3
Crack 3
Failure to zero 3
Sticking 2
Defective component 2
Device Issue 2
Air leak 2
Balloon rupture 2
Fracture 2
Unsealed device packaging 2
Malfunction 2
High Readings 2
Detachment of device or device component 2
Device Contamination with biological material 2
Difficult to open or close 1
Low readings 1
Item contaminated during manufacturing or shipping 1
Pressure issue 1
Pressure sensor failure 1
Decrease in pressure 1
Hole in material 1
False reading from device non-compliance 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
Device damaged prior to use 1
Use of Device Issue 1
Device maintenance issue 1
Material separation 1
Total Device Problems 329

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic, Inc. II Aug-25-2010

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