exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts— 510(k) K233783

Substantially Equivalent

Peca Labs, Inc.

FDA 510(k) clearance K233783 for exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts, Substantially Equivalent on 2024-01-17. Applicant: Peca Labs, Inc..

Clearance details

Applicant: Peca Labs, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2023-11-27
Decision date: 2024-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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.