VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH— 510(k) K963611

Substantially Equivalent

Vascutek, Ltd.

FDA 510(k) clearance K963611 for VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH, Substantially Equivalent on 1996-11-21. Applicant: Vascutek, Ltd..

Clearance details

Applicant: Vascutek, Ltd.
Product code: 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

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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.