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Xience V

FDA UDI

Class III (US FDA UDI)

by Abbott Vascular

Identity

Trade Name
XIENCE V FDA UDI
Generic Name
Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated FDA UDI
Device Name
XIENCE V Everolimus Eluting Coronary Stent System 4.00 mm x 15 mm / Rapid-Exchange FDA UDI
Model / Reference
1009543-15 FDA UDI
Description
XIENCE V Everolimus Eluting Coronary Stent System 4.00 mm x 15 mm / Rapid-Exchange FDA UDI

Identifiers

Catalog Number
1009543-15 FDA UDI
Primary DI / UDI-DI
08717648064418 FDA UDI
FDA Product Code
NIQ FDA UDI
GMDN Term
Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

The XIENCE V Everolimus Eluting Coronary Stent System is a non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted via a delivery catheter into a coronary artery or saphenous vein graft to maintain patency typically in patients with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Vascular

Sources (1)

  • FDA UDI 070a7440-1031-4485-b55a-dd6db51e3fae 37 fields · synced Jul 6, 2026