510(k) Report

Devices descending from K962901

2 later devices reach Olympus B5-2C/B7-2C Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250118Disposable Balloon Catheter B5-2COlympus Medical Systems Corporation20250—
+1K171492B7 2C Occlusion BalloonSpiration, Inc.20170—