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FDA 510(k)

APEEL CS CATHETER DELIVERY SYSTEM

K-Number: K031906 · 2003-07-18

ApplicantSt Jude Medical
Decision Date2003-07-18
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APEEL CS CATHETER DELIVERY SYSTEM 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 2003-07-18 under 510(k) number K031906. 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 APEEL CS CATHETER DELIVERY SYSTEM?

APEEL CS CATHETER DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-07-18. The listed applicant is St Jude Medical. The 510(k) number is K031906.

When did APEEL CS CATHETER DELIVERY SYSTEM receive FDA 510(k) clearance?

APEEL CS CATHETER DELIVERY SYSTEM received FDA 510(k) clearance on 2003-07-18, under 510(k) number K031906.

Who is the listed applicant for APEEL CS CATHETER DELIVERY SYSTEM?

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 APEEL CS CATHETER DELIVERY SYSTEM?

The FDA product code for APEEL CS CATHETER DELIVERY SYSTEM is DYB.

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Related Devices (Code: DYB)

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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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