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Wallstent Iliac Endoprosthesis

by Boston Scientific Scimed, Inc. 510(k)PMA

Active United States

PMA P940019510(k) K982184

Overview

The Wallstent Iliac Endoprosthesis is an expandable stent device manufactured by Boston Scientific Scimed, Inc. It is designed to function as an iliac prosthesis to support vascular or anatomical structures.

This device is available in diameters ranging from 6 mm through 10 mm. It is regulated under FDA PMA and 510(k) pathways, with specific authorization for the indicated size range.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK982184 Date21 Jul 1998ClearedStatusActive
United StatesFDA PMA PMA NumberP940019 Date28 May 1996ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k), FDA PMA Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

510(k) · PMA

Full name
WALLSTENT™ ILIAC RP Endoprosthesis
Trade Name
Wallstent(R) Iliac Endoprosthesis
Generic Name
STENT, ILIAC
PMA Number
510(k) Number
FDA Product Code
JCT
Device Class
Class II
Regulation
21 CFR Part 878.3720
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the intended use of the Wallstent Iliac Endoprosthesis?

    The Wallstent Iliac Endoprosthesis is an expandable stent designed to serve as an iliac prosthesis.

  • What size range is available for this endoprosthesis?

    The device is authorized for use in diameters ranging from 6 mm through 10 mm.

  • Who is the manufacturer of the Wallstent Iliac Endoprosthesis?

    This device is manufactured by Boston Scientific Scimed, Inc., located in Plymouth, Minnesota.