PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A— 510(k) K093858

Substantially Equivalent

St. Jude Medical, Cardiac Rhythm Management Divisi

FDA 510(k) clearance K093858 for PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A, Substantially Equivalent on 2010-04-02. Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi.

Clearance details

Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2009-12-16
Decision date: 2010-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.