510(k) Report

Devices descending from K040625

6 later devices reach Atad Ard Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131206Cook Cervical Ripening BalloonCook, Inc.20135—
+2K160664Aqueduct 100 Cervical DilatorGtimd, LLC20163—
+2K143424Utah CVX-RipeUtah Medical Products, Inc.20150—
+3K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC20210—
+3K202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC20200—
+3K190813CrossBay Cervical Dilator Catheter SystemCrossbay Medical20190—