GLIDER PTCA BALLOON CATHETER— 510(k) K121681

Substantially Equivalent

Trireme Medical, Inc.

FDA 510(k) clearance K121681 for GLIDER PTCA BALLOON CATHETER, Substantially Equivalent on 2012-06-26. Applicant: Trireme Medical, Inc..

Clearance details

Applicant: Trireme Medical, Inc.
Product code: Code LOX
Advisory panel: Cardiovascular
Date received: 2012-06-07
Decision date: 2012-06-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasonton, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LOX

product code LOX

Death: 190
Injury: 1,498
Malfunction: 9,670
Total: 11,358

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.