CVPRO CARDIOVASCULAR PATCH— 510(k) K943736

Name: FDA 510(k) clearance K943736
Creator: U.S. Food and Drug Administration
Published: 1995-02-22

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K943736 for CVPRO CARDIOVASCULAR PATCH, Substantially Equivalent on 1995-02-22. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code DXZ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 1994-08-02
Decision date: 1995-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

Download summary PDF View on FDA.gov ↗

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K162506 — PhotoFix Decellularized Bovine Pericardium2017-03-09
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K152127 — CorMatrix Tyke2016-02-04

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K232312 — GORE® PROPATEN® Vascular Graft2024-01-09
K233551 — GORE® ACUSEAL Vascular Graft2023-12-19
K231505 — GORE® ACUSEAL Vascular Graft2023-06-23

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.