• 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 cuff, tracheal tube, inflatable
Regulation Description Inflatable tracheal tube cuff.
Product CodeBSK
Regulation Number 868.5750
Device Class 2


Premarket Reviews
ManufacturerDecision
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
HOSPITECH RESPIRATION LTD.
  SUBSTANTIALLY EQUIVALENT 2
TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRACOE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
VORTRAN MEDICAL TECHNOLOGY 1, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 3 3
2018 4 4
2019 2 2
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Loose or Intermittent Connection 2 2
Connection Problem 2 2
Material Deformation 2 2
Inflation Problem 2 2
Incorrect Measurement 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Device Dislodged or Dislocated 1 1
Human-Device Interface Problem 1 1
Tube 1 1
Deflation Problem 1 1
Leak/Splash 1 1
Fail-Safe Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Extubate 4 4
Low Oxygen Saturation 2 2
No Known Impact Or Consequence To Patient 1 1
Dyspnea 1 1
No Consequences Or Impact To Patient 1 1
Death 1 1
Hypoxia 1 1
Complaint, Ill-Defined 1 1
Increased Respiratory Rate 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hamilton Medical, Inc. II Jan-12-2018
-
-