• 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 introducer, catheter
510(k) Number K073100
Device Name INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
Original Applicant
Oscor Inc.
3816 de soto blvd.
palm harbor,  FL  34683
Original Contact mila doskocil
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/02/2007
Decision Date 11/30/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-