Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 K092286
Device Name FOX SV PTA CATHETER
Applicant
Abbott Vascular
3200 Lakeside Drive
Santa Clara,  CA  95054
Applicant Contact NADINE SMITH
Correspondent
Abbott Vascular
3200 Lakeside Drive
Santa Clara,  CA  95054
Correspondent Contact NADINE SMITH
Regulation Number870.1250
Classification Product Code
LIT  
Date Received07/29/2009
Decision Date 08/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-