510(k) Report

Devices descending from K942709

7 later devices reach Mediastinal Silicone Drains through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961392Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IISil-Med Corp.19973—
+1K961194Antimicrobial Mediastinal Silicone DrainSil-Med Corp.19960—
+1K961295Sapphire Line Flat Drain/Kit with Spi-Argent II W/or W/Out TrocarSil-Med Corp.19961—
+2K063245Elutia Coated Closed Surgical Wound DrainBacterin International, Inc.200702
+2K012193Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc.20022—
+3K022688Versabond AB Bone CementSmith & Nephew, Inc.200401
+3K022676Orthoguard AB Antimicrobial SleeveSmith & Nephew, Inc.20020—