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 stylet, tracheal tube
Regulation Description Tracheal tube stylet.
Product CodeBSR
Regulation Number 868.5790
Device Class 1


Premarket Reviews
ManufacturerDecision
AUGUSTINE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 3
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
LAERDAL MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
RUSCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHERIDAN CATHETER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 7
Misassembled 4
Difficult to insert 3
Break 2
Tip breakage 2
Material fragmentation 2
Defective item 1
No Information 1
No code available 1
Component(s), broken 1
Air leak 1
Bent 1
Markings unclear 1
Fiberoptic break/separation 1
Flaked 1
Difficult to remove 1
Replace 1
Retraction problem 1
Material rigid or stiff 1
Shelf life exceeded 1
Source, detachment from 1
Sticking 1
Total Device Problems 36

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

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical II Jan-11-2012
2 Vital Signs Colorado Inc. II Sep-21-2008

-
-