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, Percutaneous
510(k) Number K222873
Device Name Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system
Applicant
Medtronic
8200 Coral Sea St. NE
Mounds View,  MN  55112
Applicant Contact Sarah Meyer
Correspondent
Medtronic
8200 Coral Sea St. NE
Mounds View,  MN  55112
Correspondent Contact Sarah Meyer
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/22/2022
Decision Date 11/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT04863664
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-