510(k) Report

Devices descending from K933483

15 later devices reach Opti-Plast 5F Pta Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973013Opti-Plast (Centurion) 5.5F Angioplasty CatheterVas-Cath, Inc.199813—
+1K970725Opti-Plast XL 5.5 F Pta CatheterVas-Cath, Inc.19970—
+2K040243Bard Atlas Pta Balloon Dilatation CatheterC.R. Bard, Inc.200411—
+2K021996Bolton Pta CatheterBolton Medical, Inc.20020—
+3K052236Bard Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.200510—
+4K120971Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20129—
+5K122367Bard PTV Dilatation CatheterC.R. Bard, Inc.20125—
+5K122984Atlas Gold Pta Dilatation CatheterC.R. Bard, Inc.20127—
+6K181323Atlas Gold PTA Dilatation CatheterC.R. Bard, Inc.20184—
+6K131002Vida PTV Dilataton CatheterC.R. Bard, Inc.20134—
+7K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20260—
+7K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…C.R. Bard, Inc.20222—
+7K141985True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc.20143—
+8K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20241—
+9K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20250—