ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL— 510(k) K113773

Name: FDA 510(k) clearance K113773
Creator: U.S. Food and Drug Administration
Published: 2012-01-18

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K113773 for ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL, Substantially Equivalent on 2012-01-18. Applicant: St Jude Medical. Device class: 2.

Clearance details

Applicant: St Jude Medical
Product code: Code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 2011-12-22
Decision date: 2012-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.