510(k) Report

Devices descending from K043387

8 later devices reach Vascon Polaris Guiding Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141529Alviguide Blue+ Interventional Cardiology Guiding CatheterAlvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S20140—
+1K121051Concierge Guiding CatheterMerit Medical Systems, Inc.20126—
+2K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+2K130378Respiguide Delivery SystemRespicardia20130—
+2K132409Concierge Guiding CatheterMerit Medical Systems, Inc.20134—
+3K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+3K191163Lumax Guiding CatheterCook Incorporated20190—
+3K160561Boosting CatheterQxmedical, LLC20160—