510(k) K863561— URESIL THORACIC VENT

Substantially Equivalent

Uresil Corp.

Clearance details

Applicant: Uresil Corp.
Product code: Code KDQ
Advisory panel: General Hospital
Date received: 1986-09-12
Decision date: 1986-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, US

Adverse events under product code KDQ

product code KDQ

Death: 8
Malfunction: 637
Total: 645

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.