• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name syringe, balloon inflation
510(k) Number K122152
Model AT-02003-01
Device Name OXTI INFLATION DEVICE
Original Applicant
OXTI CORPORATION
7128 staffordshire street
houston,  TX  77030
Original Contact joseph j chang
Regulation Number870.1650
Classification Product Code
MAV  
Date Received07/20/2012
Decision Date 12/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-