K121402

Substantially Equivalent

CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G

Applicant: Trireme Medical, Inc.
Product code: LIT
Advisory panel: Cardiovascular
Date received: 2012-05-10
Decision date: 2012-06-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasonton, CA, 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.