VascuCel— 510(k) K162579

Name: FDA 510(k) clearance K162579
Creator: U.S. Food and Drug Administration
Published: 2016-10-14

Substantially Equivalent

Admedus Regen Pty, Ltd.

FDA 510(k) clearance K162579 for VascuCel, Substantially Equivalent on 2016-10-14. Applicant: Admedus Regen Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Admedus Regen Pty, Ltd.
Product code: Code DXZ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2016-09-15
Decision date: 2016-10-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Malaga, AU

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

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.