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FDA 510(k)

ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM

K-Number: K053431 · 2006-03-16

ApplicantMedtronic, Ireland
Decision Date2006-03-16
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Ireland. It received FDA 510(k) clearance on 2006-03-16 under 510(k) number K053431. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM?

ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 2006-03-16. The listed applicant is Medtronic, Ireland. The 510(k) number is K053431.

When did ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM receive FDA 510(k) clearance?

ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM received FDA 510(k) clearance on 2006-03-16, under 510(k) number K053431.

Who is the listed applicant for ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM?

The FDA 510(k) record lists Medtronic, Ireland as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM?

The FDA product code for ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM is DQY.

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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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