Pacel Flow Directed Pacing Catheter— 510(k) K161873

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K161873 for Pacel Flow Directed Pacing Catheter, Substantially Equivalent on 2016-11-22. Applicant: St Jude Medical.

Clearance details

Applicant: St Jude Medical
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 2016-07-07
Decision date: 2016-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.