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


New Search Back To Search Results
Device Classification Name catheter, percutaneous
510(k) Number K122684
Device Name REVERSE MEDICAL MICROCATHETER
Original Applicant
REVERSE MEDICAL CORPORATION
13700 alton parkway suite 167
irvine,  CA  92618
Original Contact jeffrey valko
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
KRA  
Date Received08/31/2012
Decision Date 12/07/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-