INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C— 510(k) K042984

Substantially Equivalent

Intervascular

FDA 510(k) clearance K042984 for INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C, Substantially Equivalent on 2005-02-18. Applicant: Intervascular.

Clearance details

Applicant: Intervascular
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2004-10-29
Decision date: 2005-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canton, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.