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 Interventional Fluoroscopic X-Ray System
510(k) Number K243884
Device Name TAVIPILOT
Applicant
Caranx Medical
12/14 Rue Jean Antoine De Baif
Paris,  FR 75013
Applicant Contact Pierrre Berthet-Rayne
Correspondent
Caranx Medical
12/14 Rue Jean Antoine De Baif
Paris,  FR 75013
Correspondent Contact Pierrre Berthet-Rayne
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
QIH  
Date Received12/18/2024
Decision Date 07/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-