CXI SUPPORT CATHETER— 510(k) K122796

Substantially Equivalent

Cook, Inc.

FDA 510(k) clearance K122796 for CXI SUPPORT CATHETER, Substantially Equivalent on 2012-10-11. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code KRA
Advisory panel: Cardiovascular
Date received: 2012-09-12
Decision date: 2012-10-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, IN, US

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Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.