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510(k) K161985

Steerable Guide Catheter by Abbott Vascular — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2016
Date Received
July 19, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Steerable
Device Class
Class II
Regulation Number
870.1280
Review Panel
CV
Submission Type

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