K963611

Substantially Equivalent

VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH

Applicant: Vascutek, Ltd.
Product code: DXZ
Advisory panel: Cardiovascular
Date received: 1996-09-10
Decision date: 1996-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

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.