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510(k) K213584

Reprocessed NRG Transseptal Needle by Innovative Health, LLC — Product Code QLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2023
Date Received
November 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Septostomy Catheter, Reprocessed
Device Class
Class II
Regulation Number
870.5175
Review Panel
CV
Submission Type

To create or enlarge an atrial septal defect in the heart.

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Other clearances for product code QLZ

  • K200060 — Reprocessed NRG Transseptal Needle (July 30, 2020)