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 oxygenator, long term support greater than 6 hours
Product CodeBYS
Regulation Number 870.4100
Device Class 2


Premarket Reviews
ManufacturerDecision
MC3 INC.
  SUBSTANTIALLY EQUIVALENT 1
MC3 INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 5 5
2022 2 2
2023 20 20
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 16 16
Infusion or Flow Problem 12 12
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1
Partial Blockage 1 1
Leak/Splash 1 1
Increase in Pressure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
Insufficient Information 3 3
Hemorrhage/Bleeding 2 2
Unspecified Blood or Lymphatic problem 1 1
Alteration in Body Temperature 1 1
Hemolysis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mc3 Inc II Mar-19-2024
-
-