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 K250558
Device Name SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
Applicant
Medtronic, Inc.
8200 Coral Sea St. NE
Mounds View,  MN  55112
Applicant Contact Samiksha Tiwari
Correspondent
Medtronic, Inc.
8200 Coral Sea St. NE
Mounds View,  MN  55112
Correspondent Contact Samiksha Tiwari
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/25/2025
Decision Date 03/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-