← Back to catalogue

Herculink Elite RX Renal Stent System

FDA PMA

Class III (US FDA PMA)

PMA P110001

by Abbott Vascular

Identity

Trade Name
RX HERCULINK ELITE RENAL STENT SYSTEM FDA PMA
Generic Name
STENT, RENAL FDA PMA

Identifiers

PMA Number
P110001 FDA PMA
FDA Product Code
NIN FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The Herculink Elite RX Renal Stent System is a Class III renal stent designed for percutaneous placement in the renal arteries. It is intended for use in patients with atherosclerotic disease following sub-optimal percutaneous transluminal renal angioplasty (PTRA) of de novo or restenotic lesions.

This stent system is supplied sterile and intended for single-use. It is indicated for lesions up to 15 mm in length located within 10 mm of the renal ostium, with reference vessel diameters ranging from 4.0 mm to 7.0 mm. The device is approved under an FDA PMA (P110001) and is intended for use in specific clinical scenarios, such as residual stenosis (≥ 50%), significant pressure gradients, or flow-limiting dissections.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: RX Herculink Elite Renal and Biliary Stent System | Abbott, Ordering Information for RX Herculink Elite Stent System | Abbott, PDF Abbott Vascular RX Herculink Elite Renal and Biliary Stent System - U.S., PDF RX Herculink Elite® Renal and Biliary Stent System Instructions for Use

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Abbott Vascular

Sources (1)

  • FDA PMA P110001 24 fields · synced Sep 18, 2026