510(k) Report

Devices descending from K021864

2 later devices reach Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101598Emm Surgical Drape SMS W/PE Sides Model 13-005 (with Minor Dimensional Variations for…Exact Medical Manufacturing, Inc.20100—
+1K042131Promedical Surgical DrapesPromedical Products Co., Ltd.20040—