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FDA 510(k)

ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM

K-Number: K012130 · 2001-08-28

ApplicantMedtronic Vascular
Decision Date2001-08-28
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2001-08-28 under 510(k) number K012130. 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 6216 LEFT-HEART DELIVERY SYSTEM?

ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-28. The listed applicant is Medtronic Vascular. The 510(k) number is K012130.

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

ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM received FDA 510(k) clearance on 2001-08-28, under 510(k) number K012130.

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

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 6216 LEFT-HEART DELIVERY SYSTEM?

The FDA product code for ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM is DQY.

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Related Devices (Code: DQY)

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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