PressureWire X Guidewire— 510(k) K161171

Name: FDA 510(k) clearance K161171
Creator: U.S. Food and Drug Administration
Published: 2016-08-15

Substantially Equivalent

St. Jude Medical, Inc.

FDA 510(k) clearance K161171 for PressureWire X Guidewire, Substantially Equivalent on 2016-08-15. Applicant: St. Jude Medical, Inc.. Device class: 2.

Clearance details

Applicant: St. Jude Medical, Inc.
Product code: Code DXO
Device class: Class 2
Regulation: 21 CFR 870.2870
Advisory panel: Cardiovascular
Date received: 2016-04-26
Decision date: 2016-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

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.