K844922

Substantially Equivalent

PERIMETER THORACIC CATHETER

Applicant: Perimeter Medical, Inc.
Product code: GBX
Advisory panel: General, Plastic Surgery
Date received: 1984-12-19
Decision date: 1985-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

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.