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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 a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2023-04-04 under approval 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. It is manufactured by Innovative Health, LLC. The 510(k) number is K213584.

When was Reprocessed NRG Transseptal Needle approved by the FDA?

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

What company makes Reprocessed NRG Transseptal Needle?

Reprocessed NRG Transseptal Needle is manufactured by Innovative Health, LLC.

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

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

Related Clinical Trials

NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING NCT07515040 Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- Guidance RECRUITING

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Related Devices (Code: QLZ)

K200060Reprocessed NRG Transseptal NeedleInnovative Health, LLC

Official Source

View on FDA Database →

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

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