GELSOFT PLUS ERS— 510(k) K034010

Substantially Equivalent

Vascutek, Ltd.

FDA 510(k) clearance K034010 for GELSOFT PLUS ERS, Substantially Equivalent on 2004-02-19. Applicant: Vascutek, Ltd..

Clearance details

Applicant: Vascutek, Ltd.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2003-12-24
Decision date: 2004-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

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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.