510(k) Report

Devices descending from K013919

10 later devices reach Torflex Transseptal Guiding Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102948Torflex Transseptal Guiding SheathBaylis Medical Co., Inc.20119Class I
+2K183655VersaCross Transseptal SheathBaylis Medical Company, Inc.201923
+2K182064ExpanSure Transseptal Dilation SystemBaylis Medical Company, Inc.20195—
+3K231108Talon Transseptal SheathInari Medical, Inc.20230—
+3K213492Dib UltraNav Transseptal Catheter SystemDib Ultranav Medical, LLC20220—
+3K201288ExpanSure Large Access Transseptal DilatorBaylis Medical Company, Inc.20204—
+4K220414VersaCross Connect Transseptal DilatorBaylis Medical Company, Inc.20223—
+5K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.20241—
+5K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.20230—
+6K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.20250—