XO CROSS CORONARY Support Catheter— 510(k) K214107

Substantially Equivalent

Transit Scientific, LLC

FDA 510(k) clearance K214107 for XO CROSS CORONARY Support Catheter, Substantially Equivalent on 2022-04-11. Applicant: Transit Scientific, LLC.

Clearance details

Applicant: Transit Scientific, LLC
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2021-12-29
Decision date: 2022-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.