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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device injector and syringe, angiographic
Regulation Description Angiographic injector and syringe.
Product CodeDXT
Regulation Number 870.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACIST MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 7
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
ANGEION CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
ATRION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
COEUR MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 2
DEROYAL
  SUBSTANTIALLY EQUIVALENT - KIT 1
DOW
  SUBSTANTIALLY EQUIVALENT 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLOWCARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 8
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 32
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
NEMOTO KYORINDO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
OSPREY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
SCIMED
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG WEIGAO MEDICAL POLYMER CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 15
No Known Device Problem 13
Self-activation or keying 12
Foreign material present in device 11
Component(s), broken 11
Air leak 9
Device Issue 8
Unknown (for use when the device problem is not known) 6
Break 5
Disconnection 5
Device displays error message 4
Replace 3
Spillage, accidental 3
Use of Device Issue 3
Component falling 3
Loose 3
Leak 2
Electrical shorting 2
Material separation 2
Inaccurate delivery 2
Unintended system motion 2
Device operates differently than expected 2
Burst 1
Fire 1
Foreign material 1
Inaccurate synchronization 1
Tears, rips, holes in device, device material 1
Noise 1
Spark 1
Bubble(s) 1
Inaccurate flowrate 1
Device remains activated 1
Failure to calibrate 1
Dislodged or dislocated 1
Smoking 1
System fails to activate 1
Split 1
Defective item 1
No Information 1
Fluid leak 1
Overheating of device or device component 1
Other (for use when an appropriate device code cannot be identified) 1
Malfunction 1
Program, failure to 1
Sticking 1
Knotted 1
Total Device Problems 150

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 4 2 4 3 2 3 2 0 2 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Acist Medical Systems II Feb-02-2016
2 Acist Medical Systems II Apr-18-2013
3 Acist Medical Systems II Aug-30-2009
4 Acist Medical Systems II Jan-08-2009
5 Acist Medical Systems II Sep-23-2008
6 Acist Medical Systems II Dec-08-2007
7 Bayer Healthcare II Sep-16-2015
8 Lemaitre Vascular, Inc. II Oct-04-2007
9 Mallinckrodt Inc II Jul-26-2012
10 Mallinckrodt Inc II Feb-29-2012
11 Mallinckrodt Inc II Jan-19-2012
12 Mallinckrodt Inc II Sep-03-2008
13 Mallinckrodt Inc II Oct-13-2007
14 Medrad Inc II Feb-21-2013
15 Medrad Inc II Nov-02-2011
16 Medrad Inc II Jul-22-2011
17 Medrad Inc II Nov-15-2010
18 Medrad Inc II Jul-09-2010
19 Medrad Inc II Mar-23-2010
20 Medrad Inc II Jun-01-2009
21 Medrad Inc II Dec-11-2007
22 Medrad Inc dba Bayer R&I II May-28-2015
23 Merit Medical Systems, Inc. II Dec-14-2009

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