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FDA 510(k)

ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL

K-Number: K113773 · 2012-01-18

ApplicantSt Jude Medical
Decision Date2012-01-18
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2012-01-18 under 510(k) number K113773. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL?

ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL is a medical device that received FDA 510(k) clearance on 2012-01-18. The listed applicant is St Jude Medical. The 510(k) number is K113773.

When did ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL receive FDA 510(k) clearance?

ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL received FDA 510(k) clearance on 2012-01-18, under 510(k) number K113773.

Who is the listed applicant for ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL?

The FDA 510(k) record lists St Jude Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL?

The FDA product code for ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL is KRA.

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Related Devices (Code: KRA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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