• 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 K192207
Device Name Trevo NXT ProVue Retriever
47900 Bayside Parkway
Fremont,  CA  94538
Applicant Contact Rhoda M Santos
47900 Bayside Parkway
Fremont,  CA  94538
Correspondent Contact Rhoda M Santos
Regulation Number882.5600
Classification Product Code
Subsequent Product Code
Date Received08/14/2019
Decision Date 11/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No