COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR— 510(k) K971669

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K971669 for COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR, Substantially Equivalent on 1997-07-23. Applicant: Cobe Cardiovascular, Inc..

Clearance details

Applicant: Cobe Cardiovascular, Inc.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1997-05-06
Decision date: 1997-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arvada, 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.