Atlas FDA

ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID

FDA 510(k) clearance K112917 · decided 2011-10-27

Clearance details

K-number
K112917
Device name
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2011-10-03
Decision date
2011-10-27
Days to decision
24 days
Clearance type
Special
Product code
DQY
Device class
2
Regulation number
870.1250
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mounds View, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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