• 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 K121077
Device Name NHANCER
Original Applicant
ceinturrbaan noord 150
p.o. box 234
roden, drenthe,  NL 9301 nz
Original Contact e schulting
Regulation Number870.1250
Classification Product Code
Date Received04/09/2012
Decision Date 12/21/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No