HERO VASCULAR ACCESS DEVICE— 510(k) K071778

Name: FDA 510(k) clearance K071778
Creator: U.S. Food and Drug Administration
Published: 2008-01-30

Substantially Equivalent

Graftcath, Inc.

FDA 510(k) clearance K071778 for HERO VASCULAR ACCESS DEVICE, Substantially Equivalent on 2008-01-30. Applicant: Graftcath, Inc.. Device class: 2.

Clearance details

Applicant: Graftcath, Inc.
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 2007-07-02
Decision date: 2008-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prarie, MN, US

Download summary PDF View on FDA.gov ↗

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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.