CPS DIRECT SL II SLITTABLE OUTER CATHETER— 510(k) K103250

Substantially Equivalent

St. Jude Medical, Cardiac Rhythm Management Divisi

FDA 510(k) clearance K103250 for CPS DIRECT SL II SLITTABLE OUTER CATHETER, Substantially Equivalent on 2011-01-19. Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi.

Clearance details

Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2010-11-03
Decision date: 2011-01-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Sylmar, CA, 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.