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510(k) K053431

ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM by Medtronic, Ireland — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2006
Date Received
December 9, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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