INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN— 510(k) K983819

Substantially Equivalent

Intervascular, Inc.

FDA 510(k) clearance K983819 for INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN, Substantially Equivalent on 1998-11-24. Applicant: Intervascular, Inc..

Clearance details

Applicant: Intervascular, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1998-10-29
Decision date: 1998-11-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Clearwater, FL, 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.