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 sensor, blood-gas, in-line, cardiopulmonary bypass
Product CodeDTY
Regulation Number 870.4410
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 8 8
2015 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 3 3
Fluid/Blood Leak 3 3
Incorrect Or Inadequate Test Results 3 3
Battery Problem 3 3
No Display/Image 2 2
Leak/Splash 1 1
Device Operates Differently Than Expected 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
No Consequences Or Impact To Patient 4 4
No Patient Involvement 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Terumo Cardiovascular Systems Corporation II Apr-11-2011
-
-