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FDA 510(k)

ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A

K-Number: K021587 · 2002-05-30

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

Device Summary

ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A 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 K021587. 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 LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A?

ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A 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 K021587.

When did ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A receive FDA 510(k) clearance?

ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A received FDA 510(k) clearance on 2002-05-30, under 510(k) number K021587.

Who is the listed applicant for ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A?

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 LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A?

The FDA product code for ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A 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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