LDOB OCCLUSION BALLOON CATHETER— 510(k) K002286

Substantially Equivalent

Cook, Inc.

FDA 510(k) clearance K002286 for LDOB OCCLUSION BALLOON CATHETER, Substantially Equivalent on 2001-03-22. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2000-07-27
Decision date: 2001-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

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Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.