HERO GRAFT— 510(k) K124039

Name: FDA 510(k) clearance K124039
Creator: U.S. Food and Drug Administration
Published: 2013-03-07

Substantially Equivalent

Hemoshpere, Inc., A Cryolife Company

FDA 510(k) clearance K124039 for HERO GRAFT, Substantially Equivalent on 2013-03-07. Applicant: Hemoshpere, Inc., A Cryolife Company. Device class: 2.

Clearance details

Applicant: Hemoshpere, Inc., A Cryolife Company
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 2012-12-28
Decision date: 2013-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prarie, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSY

view all

K252445 — Fusion Bioline Vascular Graft2026-04-27
K252277 — Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)2025-10-20
K241550 — Gelweave Vascular Prostheses2025-02-27
K241070 — Gelsoft Plus Vascular Prostheses2024-11-15
K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft2024-03-28

Adverse events under product code DSY

product code DSY

Death: 29
Injury: 694
Total: 723

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.