CORONARY ARTERY BYPASS GRAFT (CABG) MARKER— 510(k) K871110

Name: FDA 510(k) clearance K871110
Creator: U.S. Food and Drug Administration
Published: 1987-08-27

Substantially Equivalent

Edward Weck, Inc.

FDA 510(k) clearance K871110 for CORONARY ARTERY BYPASS GRAFT (CABG) MARKER, Substantially Equivalent on 1987-08-27. Applicant: Edward Weck, Inc.. Device class: 2.

Clearance details

Applicant: Edward Weck, Inc.
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 1987-03-19
Decision date: 1987-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Pa, NC, US

Download summary PDF View on FDA.gov ↗

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K914470 — PNEUMO-SEAL(TM)1991-11-29
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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.