CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET— 510(k) K041044

Substantially Equivalent

Cook, Inc.

FDA 510(k) clearance K041044 for CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET, Substantially Equivalent on 2004-07-29. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 2004-04-22
Decision date: 2004-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

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Adverse events under product code JOH

product code JOH

Death: 42
Injury: 1,344
Malfunction: 5,608
Other: 1
Total: 6,995

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.