IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS— 510(k) K004011

Substantially Equivalent

Impra, Inc.

FDA 510(k) clearance K004011 for IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS, Substantially Equivalent on 2001-03-27. Applicant: Impra, Inc..

Clearance details

Applicant: Impra, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2000-12-27
Decision date: 2001-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, 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.