Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 pump, infusion, insulin bolus
Regulation Description Infusion pump.
Definition The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
Product CodeOPP
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
CEQUR SA
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hyperglycemia 1 1

-
-