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 K223666
Device Name Ablacath™ Mapping Catheter
Applicant
Ablacon, Inc.
4800 Wadsworth Blvd Suite 310
Wheat Ridge,  CO  80033
Applicant Contact Frank Rodriguez
Correspondent
Honkanen Consulting, Inc.
738 Saddle Wood Drive
Eagan,  MN  55123
Correspondent Contact Laurie Lewandowski
Regulation Number870.1220
Classification Product Code
MTD  
Date Received12/07/2022
Decision Date 03/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-