K221339

Substantially Equivalent

Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection

Applicant: Contego Medical, Inc.
Product code: LIT
Advisory panel: Cardiovascular
Date received: 2022-05-09
Decision date: 2022-06-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Raleigh, NC, US

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.