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FDA 510(k)

ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY

K-Number: K080428 · 2008-12-09

ApplicantMedtronic, Inc.
Decision Date2008-12-09
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2008-12-09 under 510(k) number K080428. 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 COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY?

ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY is a medical device that received FDA 510(k) clearance on 2008-12-09. The listed applicant is Medtronic, Inc.. The 510(k) number is K080428.

When did ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY receive FDA 510(k) clearance?

ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY received FDA 510(k) clearance on 2008-12-09, under 510(k) number K080428.

Who is the listed applicant for ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY?

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

What is the FDA product code for ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY?

The FDA product code for ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY 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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