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, Intracardiac Mapping, High-Density Array
510(k) Number K230253
Device Name OPTRELL™ Mapping Catheter with TRUEref™ Technology
Applicant
Biosense Webster, Inc.
31 Technology Dr. Suite 200
Irvine,  CA  92618
Applicant Contact John Jimenez
Correspondent
Biosense Webster, Inc.
31 Technology Dr. Suite 200
Irvine,  CA  92618
Correspondent Contact John Jimenez
Regulation Number870.1220
Classification Product Code
MTD  
Date Received01/31/2023
Decision Date 03/02/2023
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
-
-