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 For Crossing Total Occlusions
510(k) Number K111338
Device Name WILDCAT CATHETER
Applicant
Avinger, Inc.
755 Mathilda Ave.
Suite 100
Sunnyvale,  CA  94085
Applicant Contact KIT CARIQUITAN
Correspondent
Avinger, Inc.
755 Mathilda Ave.
Suite 100
Sunnyvale,  CA  94085
Correspondent Contact KIT CARIQUITAN
Regulation Number870.1250
Classification Product Code
PDU  
Date Received05/12/2011
Decision Date 08/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01174784
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-