• 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 i.v. start kit
Regulation Description Intravascular catheter.
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 CodeLRS
Regulation Number 880.5200
Device Class 2

Device Problems
Leak / Splash 1
Device Handling Problem 1
Loose or Intermittent Connection 1
Defective Device 1
Failure To Adhere Or Bond 1
Bent 1
Use of Device Problem 1
Total Device Problems 7

Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Feb-28-2018
2 Covidien LLC II May-31-2016
3 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Mar-09-2018
4 Windstone Medical Packaging, Inc. II Jun-01-2016