Skip to content

TREO Abdominal Stent-Graft System 28-S2-11-080U

by Bolton Medical Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00843576151956 UDI-DI Date2 Feb 2021ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1689-2023 FDA Class II initiated 3 May 2023

    Potential for the incorrect size stent-graft than the printed carton label.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
TREO Abdominal Stent-Graft System
Generic Name
Aortoiliac endovascular stent-graft
Model / Ref / Catalog
28-S2-11-080U
Primary DI / UDI-DI
00843576151956
PMA Number
FDA Product Code
MIH
GMDN Term
Aortoiliac endovascular stent-graft
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Outer Diameter — 11 Millimeter
Length — 79 Millimeter
Catheter Gauge — 13 French

Related devices

Category: Aortoiliac endovascular stent-graft

Cleared under the same submission (P190015)

Show all (12)

Other devices from Bolton Medical Inc.

See all devices from Bolton Medical Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No