MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM— 510(k) K012898

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K012898 for MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM, Substantially Equivalent on 2001-09-17. Applicant: Cobe Cardiovascular, Inc..

Clearance details

Applicant: Cobe Cardiovascular, Inc.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 2001-08-29
Decision date: 2001-09-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Arvada, CO, US

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Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.