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 Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K251207
Device Name Sangria™ Thrombectomy System
Applicant
Avantec Vascular Corporation
870 Hermosa Dr.
Sunnyvale,  CA  94085
Applicant Contact Jack Hoshino
Correspondent
Avantec Vascular Corporation
870 Hermosa Dr.
Sunnyvale,  CA  94085
Correspondent Contact Gene Reu
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
BTA  
Date Received04/18/2025
Decision Date 01/07/2026
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
-
-