VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA— 510(k) K896338

Substantially Equivalent

Voss Medical Products

FDA 510(k) clearance K896338 for VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA, Substantially Equivalent on 1990-05-17. Applicant: Voss Medical Products.

Clearance details

Applicant: Voss Medical Products
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 1989-11-03
Decision date: 1990-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.