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510(k) K221397

MitraClip G4 Steerable Guide Catheter by Abbott Medical — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2022
Date Received
May 13, 2022
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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