CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter— 510(k) K142235

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K142235 for CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter, Substantially Equivalent on 2014-12-18. Applicant: St Jude Medical.

Clearance details

Applicant: St Jude Medical
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2014-08-13
Decision date: 2014-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
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.