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510(k) K192996

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool by Biotronik, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2019
Date Received
October 28, 2019
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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