510(k) Report

Devices descending from K962925

3 later devices reach Olympus B-5/B-7 Seriesballoon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250409Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable…Olympus Medical Systems Corporation20250—
+1K033333Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-BAomori Olympus Co., Ltd.20031—
+2K091495Single Use 3-Lumen Extraction Balloon V, Model V…Olympus Medical Systems Corporation200903