510(k) Report

Devices descending from K161921

4 later devices reach SwiftNINJA Microcatheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211110Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc.20220—
+1K211525SwiftNINJA Steerable MicrocatheterMerit Medical Systems, Inc.20210—
+1K190126Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd.20192—
+2K200582Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd.20201—