exGraft, exGraft Carbon— 510(k) K183613

Substantially Equivalent

Peca Labs

FDA 510(k) clearance K183613 for exGraft, exGraft Carbon, Substantially Equivalent on 2019-04-22. Applicant: Peca Labs.

Clearance details

Applicant: Peca Labs
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2018-12-26
Decision date: 2019-04-22
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.