INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER— 510(k) K022242

Substantially Equivalent

Intervascular

FDA 510(k) clearance K022242 for INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER, Substantially Equivalent on 2002-08-14. Applicant: Intervascular.

Clearance details

Applicant: Intervascular
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2002-07-11
Decision date: 2002-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellesley, MA, 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.