SULZER CARBOMEDICS CARDIOFIX PERICARDIUM— 510(k) K993288

Name: FDA 510(k) clearance K993288
Creator: U.S. Food and Drug Administration
Published: 1999-12-29

Substantially Equivalent

Sulzer Carbomedics, Inc.

FDA 510(k) clearance K993288 for SULZER CARBOMEDICS CARDIOFIX PERICARDIUM, Substantially Equivalent on 1999-12-29. Applicant: Sulzer Carbomedics, Inc.. Device class: 2.

Clearance details

Applicant: Sulzer Carbomedics, Inc.
Product code: Code DXZ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 1999-10-01
Decision date: 1999-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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K023185 — ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 8002002-12-17
K013022 — SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS2002-06-13
K021051 — ANNULOFLO SYSTEM, MITRAL MODEL AR7002002-04-23
K002007 — SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS2001-01-25
K992056 — ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF8001999-10-12

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.