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 K173841
FOIA Releasable 510(k) K173841
Device Name AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm
Applicant
Stryker
47900 Bayside Pkwy.
Fremont,  CA  94538
Applicant Contact Angelica Beckmann
Correspondent
Stryker
47900 Bayside Pkwy.
Fremont,  CA  94538
Correspondent Contact Angelica Beckmann
Regulation Number870.1250
Classification Product Code
NRY  
Subsequent Product Code
DQY  
Date Received12/18/2017
Decision Date 03/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-