510(k) Report

Devices descending from K970854

7 later devices reach 5 FR and 6 FR Infiniti Angiographic Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232573INFINITI™ Ambi Angiographic CatheterCordis US Corp20230—
+1K102633Bioteq Angiographic CatheterBioteque Corp.20110—
+1K090427Ursa Angiographic CatheterCurative Medical Technology, Inc.20101—
+1K051561Asahi Angiographic CatheterAsahi Intecc Co., Ltd.20052—
+2K123818Ursa Angiographic CatheterCurative Medical Technology, Inc.20130—
+2K082559Spectranetics Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp.20081—
+3K090913Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp.20090—