Home › Device types › NIU
Stent, Superficial Femoral Artery, Drug-Eluting
FDA product code NIU · Class 3 · Unknown
61
Registered devices
2,846
Adverse events
3
Recalls
0
510(k) clearances
Devices with this code
ELUVIA™ — BOSTON SCIENTIFIC CORPORATIONZilver PTX — COOK IRELAND LTDZilver PTX — COOK IRELAND LTDZilver PTX — COOK IRELAND LTDZilver PTX — COOK IRELAND LTDZilver PTX — COOK IRELAND LTDELUVIA™ — BOSTON SCIENTIFIC CORPORATIONELUVIA™ — BOSTON SCIENTIFIC CORPORATIONZilver PTX — COOK IRELAND LTDZilver PTX — COOK IRELAND LTDELUVIA™ — BOSTON SCIENTIFIC CORPORATIONELUVIA™ — BOSTON SCIENTIFIC CORPORATIONZilver PTX — COOK IRELAND LTDZilver PTX — COOK IRELAND LTDZilver PTX — COOK IRELAND LTDZilver PTX — COOK IRELAND LTDZilver PTX — COOK IRELAND LTDZilver PTX — COOK IRELAND LTDELUVIA™ — BOSTON SCIENTIFIC CORPORATIONELUVIA™ — BOSTON SCIENTIFIC CORPORATIONELUVIA™ — BOSTON SCIENTIFIC CORPORATIONZilver PTX — COOK IRELAND LTDZilver PTX — COOK IRELAND LTDZilver PTX — COOK IRELAND LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-21 | Boston Scientific Corporation | One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging. |
| 2013-04-18 | Cook, Inc. | Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of th |
| 2013-04-18 | Cook, Inc. | Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of th |
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