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FDA 510(k)

AGILLS PF DELIVERY SYSTEM

K-Number: K111943 · 2011-09-29

ApplicantSt. Jude Medical, Cardiac Rhythm Management Divisi
Decision Date2011-09-29
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AGILLS PF DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Cardiac Rhythm Management Divisi. It received FDA 510(k) clearance on 2011-09-29 under 510(k) number K111943. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGILLS PF DELIVERY SYSTEM?

AGILLS PF DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-29. The listed applicant is St. Jude Medical, Cardiac Rhythm Management Divisi. The 510(k) number is K111943.

When did AGILLS PF DELIVERY SYSTEM receive FDA 510(k) clearance?

AGILLS PF DELIVERY SYSTEM received FDA 510(k) clearance on 2011-09-29, under 510(k) number K111943.

Who is the listed applicant for AGILLS PF DELIVERY SYSTEM?

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

What is the FDA product code for AGILLS PF DELIVERY SYSTEM?

The FDA product code for AGILLS PF DELIVERY SYSTEM is DYB.

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Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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