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, thrombus retriever
510(k) Number K191768
Device Name AXS Vecta Aspiration System
Applicant
Stryker Neurovascular
47900 Bayside Parkway
Fremont,  CA  94538
Applicant Contact Shazia Hakim
Correspondent
Stryker Neurovascular
47900 Bayside Parkway
Fremont,  CA  94538
Correspondent Contact Shazia Hakim
Regulation Number870.1250
Classification Product Code
NRY  
Date Received07/01/2019
Decision Date 07/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-