HERO VASCULAR ACCESS DEVICE— 510(k) K091491

Name: FDA 510(k) clearance K091491
Creator: U.S. Food and Drug Administration
Published: 2009-07-31

Substantially Equivalent

Hemosphere, Inc.

FDA 510(k) clearance K091491 for HERO VASCULAR ACCESS DEVICE, Substantially Equivalent on 2009-07-31. Applicant: Hemosphere, Inc.. Device class: 2.

Clearance details

Applicant: Hemosphere, Inc.
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 2009-05-20
Decision date: 2009-07-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Eden Prarie, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSY

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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

More clearances from Hemosphere, Inc.

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K121532 — HERO GRAFT2012-06-22
K120006 — HERO GRAFT2012-02-02

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.