COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED— 510(k) K993001

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K993001 for COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED, Substantially Equivalent on 1999-12-03. Applicant: Cobe Cardiovascular, Inc..

Clearance details

Applicant: Cobe Cardiovascular, Inc.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1999-09-07
Decision date: 1999-12-03
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.