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510(k) K012225

ATTAIN 6215 VENOGRAM BALLOON CATHETER by Medtronic Vascular — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2001
Date Received
July 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Flow Directed
Device Class
Class II
Regulation Number
870.1240
Review Panel
CV
Submission Type

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