CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE— 510(k) K120298

Name: FDA 510(k) clearance K120298
Creator: U.S. Food and Drug Administration
Published: 2012-05-08

Substantially Equivalent

St. Jude Medical, Cardiac Rhythm Management Divisi

FDA 510(k) clearance K120298 for CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE, Substantially Equivalent on 2012-05-08. Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi. Device class: 2.

Clearance details

Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2012-01-31
Decision date: 2012-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

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K093858 — PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A2010-04-02

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.