VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES— 510(k) K853101

Name: FDA 510(k) clearance K853101
Creator: U.S. Food and Drug Administration
Published: 1986-02-24

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K853101 for VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES, Substantially Equivalent on 1986-02-24. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 1985-07-23
Decision date: 1986-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSY

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K252445 — Fusion Bioline Vascular Graft2026-04-27
K252277 — Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)2025-10-20
K241550 — Gelweave Vascular Prostheses2025-02-27
K241070 — Gelsoft Plus Vascular Prostheses2024-11-15
K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft2024-03-28

More clearances from Cobe Laboratories, Inc.

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K923272 — COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR1993-05-11
K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC1991-03-22
K905793 — COBE CENTRY 2 BICART OPTION KIT1991-02-12
K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT1991-02-11
K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR1990-12-27

Adverse events under product code DSY

product code DSY

Death: 29
Injury: 694
Total: 723

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.