STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE— 510(k) K001509

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K001509 for STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE, Substantially Equivalent on 2001-10-26. Applicant: Cobe Cardiovascular, Inc..

Clearance details

Applicant: Cobe Cardiovascular, Inc.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2000-05-15
Decision date: 2001-10-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Arvada, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.