PERCUTANEOUS TRACHEOSTOMY TUBE KIT— 510(k) K931611

Unknown

Crandall Medical Devices

FDA 510(k) clearance K931611 for PERCUTANEOUS TRACHEOSTOMY TUBE KIT, Unknown on 1993-08-27. Applicant: Crandall Medical Devices.

Clearance details

Applicant: Crandall Medical Devices
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 1993-04-01
Decision date: 1993-08-27
Decision: Unknown
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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.