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 Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
510(k) Number K223305
Device Name Trevo NXT ProVue Retriever
Applicant
Stryker Neurovascular
47900 Bayside Parkway
Fremont,  CA  94538
Applicant Contact Heli Chambi
Correspondent
Stryker Neurovascular
47900 Bayside Parkway
Fremont,  CA  94538
Correspondent Contact Heli Chambi
Regulation Number882.5600
Classification Product Code
POL  
Subsequent Product Code
NRY  
Date Received10/27/2022
Decision Date 03/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-