CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)— 510(k) K120677

Substantially Equivalent

Trireme Medical, Inc.

FDA 510(k) clearance K120677 for CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014), Substantially Equivalent on 2012-03-15. Applicant: Trireme Medical, Inc..

Clearance details

Applicant: Trireme Medical, Inc.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2012-03-06
Decision date: 2012-03-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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.