510(k) Report

Devices descending from K831769

8 later devices reach Various Cardiovascular Surgical Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123370EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating, Dispersion…Edwards Lifesciences, LLC201314
+1K113411Edward Vent Catheters Edward Vent Catheters with Duraflo Coating Dispersion Aortic…Edwards Lifesciences, LLC201201
+1K120072Venous Drainage Cannula with Duraflo CoatingEdwards Lifesciences, LLC201204
+1K974259Venous Flex II Peripheral and Intra-Operative Access Venous Return CannulaeEdwards Lifesciences Research Medical19983—
+2K233895EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA…Edwards Lifesciences20240—
+2K091542Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech20091—
+2K991541A-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44A-Med Systems, Inc.19990—
+3K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L.20250—