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Reprocessed NRG Transseptal Needle

by Innovative Health LLC 510(k)

Active United States

510(k) K200060

Overview

The Reprocessed NRG Transseptal Needle is a medical device used to create an atrial septal defect in the heart. It is also employed for monitoring intracardiac pressures, sampling blood, and infusing solutions.

The device is supplied as a single-use, reprocessed item and must be used with the BMC Connector Cable to ensure patient and operator safety. It is regulated under FDA 510(k) clearance (K200060) and is intended for use by trained healthcare professionals.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200060 Date30 Jul 2020ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
QLZ
FDA applicant
Innovative Health, LLC
Device Class
Class II
Regulation
21 CFR Part 870.5175
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Innovative Health, LLC.

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Questions

  • What is the Reprocessed NRG Transseptal Needle used for?

    This device is used to create an atrial septal defect in the heart. It is also employed for monitoring intracardiac pressures, sampling blood, and infusing solutions.

  • Is the Reprocessed NRG Transseptal Needle intended for single use?

    Yes, the device is supplied as a single-use, reprocessed item. It must be used with the BMC Connector Cable to ensure patient and operator safety.

  • What is the regulatory status of the Reprocessed NRG Transseptal Needle?

    The device is regulated under FDA 510(k) clearance (K200060). It is intended for use by trained healthcare professionals.

  • What is the advisory committee review for this device?

    The device was reviewed by the Cardiovascular (CV) advisory committee.