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510(k) K200721

Agilis HisPro Steerable Catheter With Electrodes by Abbott (St. Jude Medical) — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2020
Date Received
March 19, 2020
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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