510(k) Report

Devices descending from K960715

7 later devices reach Pruitt-Inahara Carotid Shunt 400-40-8F/Inahara-Pruitt Carotid Shunt 500-50-8F through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043023Pruitt-Inahara Outlying Carotid Shunt, Models, 2012-49, 2013-49…LeMaitre Vascular, Inc.20046—
+2K051067Pruitt F3 Outlying and Inlying Carotid Shunt (with and Without T-Port)LeMaitre Vascular, Inc.200551
+3K182916Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt…Lemaitre Vascular20180—
+3K143454Pruitt F3-S Carotid ShuntLeMaitre Vascular, Inc.20151—
+3K103356Pruitt Carotid KitLeMaitre Vascular, Inc.20100—
+3K071367Flexcel Carotid Shunt (Inlying), Model 2020-05LeMaitre Vascular, Inc.20070—
+4K152833Pruitt F3-S Polyurethane Carotid ShuntLeMaitre Vascular, Inc.201601