CORONARY ANASTOMOSIS MARKING SYSTEM— 510(k) K832806

Name: FDA 510(k) clearance K832806
Creator: U.S. Food and Drug Administration
Published: 1983-09-29

Substantially Equivalent

Biotrac Laboratories

FDA 510(k) clearance K832806 for CORONARY ANASTOMOSIS MARKING SYSTEM, Substantially Equivalent on 1983-09-29. Applicant: Biotrac Laboratories. Device class: 2.

Clearance details

Applicant: Biotrac Laboratories
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 1983-08-18
Decision date: 1983-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K241550 — Gelweave Vascular Prostheses2025-02-27
K241070 — Gelsoft Plus Vascular Prostheses2024-11-15
K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft2024-03-28

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K843216 — ECLIPSE HEART SUPPORT FOR CORONARY ARTER1984-09-20

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.