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 dilator, catheter
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGCC
Regulation Number 878.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
MED INSTITUTE, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Delivered as unsterile product 3
Other (for use when an appropriate device code cannot be identified) 2
Tear, rip or hole in device packaging 1
Sterility 1
Bent 1
Fracture 1
Total Device Problems 9

-
-