BLADE SEPTOSTOMY CATHETER— 510(k) K801031

Substantially Equivalent

Cook, Inc.

FDA 510(k) clearance K801031 for BLADE SEPTOSTOMY CATHETER, Substantially Equivalent on 1980-07-28. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code DXF
Advisory panel: Cardiovascular
Date received: 1980-05-01
Decision date: 1980-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXF

product code DXF

Death: 78
Injury: 1,126
Malfunction: 507
Other: 1
Total: 1,712

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.