COBE ICU CONVERSION KIT— 510(k) K902631

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K902631 for COBE ICU CONVERSION KIT, Substantially Equivalent on 1990-12-17. Applicant: Cobe Laboratories, Inc..

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1990-06-14
Decision date: 1990-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

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Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.