THORACIC CATHTER STYLET— 510(k) K913539

Substantially Equivalent

Intl. Medical Devices , Ltd.

FDA 510(k) clearance K913539 for THORACIC CATHTER STYLET, Substantially Equivalent on 1992-01-21. Applicant: Intl. Medical Devices , Ltd..

Clearance details

Applicant: Intl. Medical Devices , Ltd.
Product code: Code GBX
Advisory panel: General, Plastic Surgery
Date received: 1991-08-09
Decision date: 1992-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.