510(k) Report

Devices descending from K863354

3 later devices reach Bio-Guard AB Coated Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012193Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc.20022—
+2K022688Versabond AB Bone CementSmith & Nephew, Inc.200401
+2K022676Orthoguard AB Antimicrobial SleeveSmith & Nephew, Inc.20020—