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FDA 510(k)

Reprocessed NRG Transseptal Needle

K-Number: K213584 · 2023-04-04

ApplicantInnovative Health, LLC
Decision Date2023-04-04
Product CodeQLZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed NRG Transseptal Needle is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2023-04-04 under 510(k) number K213584. The device is classified under product code QLZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed NRG Transseptal Needle?

Reprocessed NRG Transseptal Needle is a medical device that received FDA 510(k) clearance on 2023-04-04. The listed applicant is Innovative Health, LLC. The 510(k) number is K213584.

When did Reprocessed NRG Transseptal Needle receive FDA 510(k) clearance?

Reprocessed NRG Transseptal Needle received FDA 510(k) clearance on 2023-04-04, under 510(k) number K213584.

Who is the listed applicant for Reprocessed NRG Transseptal Needle?

The FDA 510(k) record lists Innovative Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed NRG Transseptal Needle?

The FDA product code for Reprocessed NRG Transseptal Needle is QLZ.

Other records listing Innovative Health, LLC as applicant

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Related Devices (Code: QLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200060Reprocessed NRG Transseptal NeedleInnovative Health, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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