Natec Medical , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251915Amethyst HP PTA OTW 0.035 CatheterDecember 18, 2025
K241040Amethyst HP PTA OTW 0.035 CatheterDecember 18, 2024
K220410Ebony HP PTA OTW 0.035 CatheterJune 29, 2022
K210012Tamarin Blue PTCA RX Dilatation CatheterJuly 9, 2021
K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterSeptember 3, 2015
K141933FILAO NC RX PTCA DILATATION CATHETERJune 28, 2015
K143041Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire CatheterJune 4, 2015
K143036Ebony PTA 0.035 Peripheral Dilatation CatheterMarch 30, 2015
K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterFebruary 3, 2015
K112735TAMARIN BLUE PTCA RX DILATATION CATHETERNovember 2, 2012
K112513EBONY PTA 0.014 PERIPHERAL DILATATION CATHETERDecember 9, 2011
K103354EBONY PTA .035 PERIPHERAL DILATATION CATHETERFebruary 23, 2011