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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device device, fixation, tracheal tube
Regulation Description Tracheal tube fixation device.
Product CodeCBH
Regulation Number 868.5770
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOSEAL
  SUBSTANTIALLY EQUIVALENT 1
DALE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ERGOMED
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Normal 13
Increase in pressure 2
Material erosion 2
Device abrasion from instrument or another object 2
Method, improper/incorrect 1
Break 1
Dislodged 1
Disposable 1
Total Device Problems 23

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Dale Medical Products, Inc. II Jan-11-2008

-
-