510(k) K233825

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter by Innovative Health — Product Code NLH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 7, 2024
Date Received: December 1, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

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

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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