• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device angiography/angioplasty kit
Regulation Description Angiographic injector and syringe.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOEQ
Regulation Number 870.1650
Device Class 2

Device Problems
Material Integrity Problem 6
Crack 4
Tear, Rip or Hole in Device Packaging 4
Material Separation 3
Device Contamination with Chemical or Other Material 3
Fracture 3
Unsealed Device Packaging 3
Material Protrusion / Extrusion 2
Contamination / decontamination Problem 2
Break 2
Unraveled Material 1
Material Deformation 1
Device Contaminated during manufacture or shipping 1
Mechanical Problem 1
Packaging Problem 1
Fluid Leak 1
Connection Problem 1
Device Misassembled During Manufacturing / Shipping 1
Leak / Splash 1
Loose or Intermittent Connection 1
Material Fragmentation 1
Manufacturing, Packaging or Shipping Problem 1
Total Device Problems 44

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 Angiodynamics Inc. (Navilyst Medical Inc.) II Apr-17-2018
3 Customed, Inc II Apr-14-2016
4 Customed, Inc II Sep-03-2015
5 Merit Medical Systems, Inc. II Apr-13-2020
6 Merit Medical Systems, Inc. II Oct-01-2019
7 Navilyst Medical, Inc II Feb-26-2015

-
-