DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Vascutek, Ltd.
Product code
Code DXZ
Device class
Class 2
Regulation
21 CFR 870.3470
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Austin, TX, US
Download summary PDFView on FDA.gov ↗

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More clearances from Vascutek, Ltd.

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Adverse events under product code DXZ

product code DXZ
Death
19
Injury
265
Total
284

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K963611

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K963611.

Data sourced from openFDA. This site is unofficial and independent of the FDA.