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FDA 510(k)

ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218

K-Number: K021589 · 2002-05-30

ApplicantMedtronic Vascular
Decision Date2002-05-30
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2002-05-30 under 510(k) number K021589. 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 ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218?

ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 is a medical device that received FDA 510(k) clearance on 2002-05-30. The listed applicant is Medtronic Vascular. The 510(k) number is K021589.

When did ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 receive FDA 510(k) clearance?

ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 received FDA 510(k) clearance on 2002-05-30, under 510(k) number K021589.

Who is the listed applicant for ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218?

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

What is the FDA product code for ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218?

The FDA product code for ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 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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