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 Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K233647
Device Name VersaCross Connect™ Transseptal Dilator
Applicant
Baylis Medical Company, Inc.
5825 Explorer Dr.
Mississauga,  CA L4W5P6
Applicant Contact Christina Dowd
Correspondent
Baylis Medical Company, Inc.
5825 Explorer Dr.
Mississauga,  CA L4W5P6
Correspondent Contact Christina Dowd
Regulation Number870.1310
Classification Product Code
DRE  
Date Received11/14/2023
Decision Date 12/14/2023
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
-
-