510(k) Report

Devices descending from K043023

6 later devices reach Pruitt-Inahara Outlying Carotid Shunt, Models, 2012-49, 2013-49… through their predicates, nearest generation first.

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