• 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 | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K143036
Device Name Ebony PTA 0.035 Peripheral Dilatation Catheter
Applicant
Natec Medical Ltd
Maeva Centre Building Ebene Business Park
Reduit,  MU 72201
Applicant Contact Xavier De Buchere
Correspondent
CardioMed Device Consultants, LLC
5523 Research Park Drive
Suite 205
Baltimore,  MD  21228
Correspondent Contact Judith Danielson
Regulation Number870.1250
Classification Product Code
LIT  
Date Received10/22/2014
Decision Date 03/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-