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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 1
  SUBSTANTIALLY EQUIVALENT - KIT 1

Device Problems
Incorrect measurement 75
Unable to obtain readings 55
Incorrect display 48
Inflation issue 40
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 12
Foreign material present in device 12
Device operates differently than expected 11
Tear, rip or hole in device packaging 11
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 6
Measurements, inaccurate 4
Crack 4
Delivered as unsterile product 4
Contamination during use 4
Bubble(s) 3
No Information 3
Pressure issue 3
Failure to zero 3
Sticking 2
Device Contamination with biological material 2
Device Issue 2
Air leak 2
Unsealed device packaging 2
Detachment of device or device component 2
Malfunction 2
Defective component 2
Low readings 2
Unstable 2
Fracture 2
High Readings 2
Balloon rupture 2
Difficult to open or close 1
Use of Device Issue 1
Pressure sensor failure 1
No Known Device Problem 1
False reading from device non-compliance 1
Display misread 1
Material rupture 1
Meter failure 1
Device markings issue 1
Erratic display 1
Material perforation 1
Component(s), broken 1
No device output 1
Packaging issue 1
Material separation 1
Hole in material 1
Seal, defective 1
Device maintenance issue 1
Item contaminated during manufacturing or shipping 1
Decrease in pressure 1
Total Device Problems 485

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 0 0 0 2 0 1 0
Class III 0 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Vascular III Feb-26-2014
2 Medtronic, Inc. II Aug-25-2010
3 Merit Medical Systems, Inc. II Oct-03-2016
4 PEROUSE MEDICAL II Dec-29-2014
5 Perouse Medical II Jul-22-2014

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