VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN— 510(k) K861808

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K861808 for VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN, Substantially Equivalent on 1986-09-15. Applicant: Cobe Laboratories, Inc..

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1986-05-09
Decision date: 1986-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

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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.