510(k) Report

Devices descending from K182064

5 later devices reach ExpanSure Transseptal Dilation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201288ExpanSure Large Access Transseptal DilatorBaylis Medical Company, Inc.20204—
+2K220414VersaCross Connect Transseptal DilatorBaylis Medical Company, Inc.20223—
+3K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.20241—
+3K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.20230—
+4K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.20250—