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 K201330
Device Name Tigereye CTO-Crossing Catheter
Applicant
Avinger, Inc.
400 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact Thomas Lawson
Correspondent
Avinger, Inc.
400 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact Thomas Lawson
Regulation Number870.1250
Classification Product Code
PDU  
Subsequent Product Code
NQQ  
Date Received05/19/2020
Decision Date 09/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-