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 K214114
Device Name Prodigy Thrombectomy System
Applicant
Truvic Medical, Inc.
1359 Dell Ave.
Campbell,  CA  95008
Applicant Contact Micheal Buck
Correspondent
Cardiomed Device Consultants
1783 Forest Dr.
Suite 254
Annappolis,  MD  21401
Correspondent Contact Semih Oktay
Regulation Number870.5150
Classification Product Code
QEW  
Date Received12/30/2021
Decision Date 04/06/2022
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
-
-