510(k) Report

Devices descending from K895207

8 later devices reach Bioclusive* Transparent Film Dressing - New Claim through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080620Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care200871
+2K1719083M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company201701
+2K1534103M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company201711
+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—