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510(k) K121839

UNBALLOON NON-OCCLUSIVE MODELING CATHETER by LeMaitre Vascular, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2012
Date Received
June 22, 2012
Clearance Type
Special
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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