510(k) Report

Devices descending from K970054

8 later devices reach Tandemrx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041827Dualflex RX Ercp Cannula, Models 4681, 4682Boston Scientific Corp20040—
+1K010610Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527Boston Scientific Corp20016—
+2K210353AutoCap RXBoston Scientific Corporation20210—
+2K040137Wilson-Cook Usw Cap and Wire LockWilson-Cook Medical, Inc.20044—
+3K213483SnapLoc Wire LockWilson Cook Medical20220—
+3K220247Guidewire Locking DeviceMicro-Tech (Nanjing) Co., Ltd.20220—
+3K202237Locking deviceHangzhou AGS MedTech Co., Ltd.20200—
+3K190164CleverLock Guidewire Locking Device and Biopsy CapOlympus Surgical Technologies America20190—