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510(k) K191880

Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter by Innovative Health, LLC — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2019
Date Received
July 15, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

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