510(k) Report

Devices descending from K063458

16 later devices reach 3M Tegaderm CHG Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1719083M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company201701
+1K1534103M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company201711
+1K1236793M Tegaderm CHG Chlorhexidine Gluconate I.V. Port Dressing3M Company201311
+1K113836Benehold CHG Transparent Film Dressing (10X12CM) (8.5X12CM) (6.5X7 CM)Avery Dennison Belgie Bvba20124—
+1K103106Chlorashield TM Antimicrobial DressingCare Fusion 213, LLC20110—
+1K080620Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care200871
+2K2008353M Tegaderm CHG Chlorhexidine Gluconate Gel Pad3M Company202001
+2K1707543M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced…3M Company, 3M Healthcare20170—
+2K170407BD ChloraShield IV Dressing with CHG AntimicrobialAvery Dennison Belgie Bvba20170—
+2K152923BD ChloraShield IV Dressing with CHG AntimicrobialAvery Dennison Belgie Bvba20150—
+2K133764Chlorashield IV Dressing with CHG AntimicrobialAvery Dennison Belgie Bvba20140—
+2K121819Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc.20123—
+2K112549IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc.20120—
+3K163529ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG…Avery Dennison Corporation20171—
+3K140389Chloraderm Antimicrobial Transparent Thin Film Dressing, 2 3/8 X 2 3/4, 4 X 4 3/4Entrotech Life Sciences, Inc.20140—
+4K251866Tegaderm Post-Op Transparent Antimicrobial DressingSolventum US, LLC20250—