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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device syringe, balloon inflation
Regulation Description Angiographic injector and syringe.
Product CodeMAV
Regulation Number 870.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1

Device Problems
Gauges/Meters 158
Leak / Splash 150
Device Packaging Compromised 109
Inaccurate Information 108
Incorrect Measurement 107
Display or Visual Feedback Problem 100
Device Contamination with Chemical or Other Material 65
Tear, Rip or Hole in Device Packaging 49
Break 46
Label 21
Device Damaged Prior to Use 16
Packaging Problem 16
Improper Device Output 12
Device Operates Differently Than Expected 12
Incorrect, Inadequate or Imprecise Result or Readings 9
Inflation Problem 8
Detachment Of Device Component 8
Crack 8
Pressure Problem 8
Loose or Intermittent Connection 8
Physical Resistance / Sticking 7
Material Separation 7
Adverse Event Without Identified Device or Use Problem 6
Unable to Obtain Readings 5
Delivered as Unsterile Product 5
Material Puncture / Hole 5
Device Contaminated during manufacture or shipping 4
Fitting Problem 4
Suction Problem 4
Seal 4
Unsealed Device Packaging 3
Appropriate Term/Code Not Available 3
Noise, Audible 3
Detachment of Device or device Component 3
Fluid Leak 3
Insufficient Information 3
Misconnection 3
Deflation Problem 3
Product Quality Problem 3
Balloon 2
No Pressure 2
Unstable 2
No Device Output 2
Increase in Pressure 2
Improper or Incorrect Procedure or Method 2
Calibration Problem 1
Contamination / decontamination Problem 1
Decrease in Pressure 1
Air Leak 1
Fracture 1
Difficult to Remove 1
Contamination During Use 1
Display Difficult to Read 1
Difficult to Insert 1
Device Markings / Labelling Problem 1
Difficult to Open or Remove Packaging Material 1
Catheter 1
Defective Device 1
Connector 1
Cuff 1
Housing 1
Occlusion Within Device 1
Material Rupture 1
Mechanical Problem 1
Retraction Problem 1
Device Dislodged or Dislocated 1
Device Issue 1
Material Integrity Problem 1
Guidewire 1
Total Device Problems 1132

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Feb-27-2019
2 Boston Scientific Corporation II Aug-16-2017
3 DeRoyal Industries Inc II Jun-29-2017
4 Merit Medical Systems, Inc. II Oct-03-2016
5 PEROUSE MEDICAL II Apr-28-2017
6 Vascular Solutions, Inc. II May-31-2017

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