510(k) Report

Devices descending from K201288

4 later devices reach ExpanSure Large Access Transseptal Dilator through their predicates, nearest generation first.

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