• 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 filter, blood, cardiopulmonary bypass, arterial line
Regulation Description Cardiopulmonary bypass arterial line blood filter.
Product CodeDTM
Regulation Number 870.4260
Device Class 2


Premarket Reviews
ManufacturerDecision
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
TRANSMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 4 4
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 3 3
Leak/Splash 1 1
Connection Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Improper Flow or Infusion 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Noise, Audible 1 1
Coagulation in Device or Device Ingredient 1 1
Material Puncture/Hole 1 1
Fluid/Blood Leak 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10

-
-