510(k) Report

Devices descending from K904669

7 later devices reach Balloon Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962925Olympus B-5/B-7 Seriesballoon CatheterOlympus America, Inc.199635
+1K962901Olympus B5-2C/B7-2C Balloon CatheterOlympus America, Inc.19962—
+2K250409Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable…Olympus Medical Systems Corporation20250—
+2K250118Disposable Balloon Catheter B5-2COlympus Medical Systems Corporation20250—
+2K171492B7 2C Occlusion BalloonSpiration, Inc.20170—
+2K033333Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-BAomori Olympus Co., Ltd.20031—
+3K091495Single Use 3-Lumen Extraction Balloon V, Model V…Olympus Medical Systems Corporation200903