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FDA 510(k)

Reprocessed BRK Transseptal Needle

K-Number: K192998 · 2020-07-22

ApplicantInnovative Health, LLC
Decision Date2020-07-22
Product CodeNMK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed BRK Transseptal Needle is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2020-07-22 under approval number K192998. The device is classified under product code NMK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed BRK Transseptal Needle?

Reprocessed BRK Transseptal Needle is a medical device that received FDA 510(k) clearance on 2020-07-22. It is manufactured by Innovative Health, LLC. The 510(k) number is K192998.

When was Reprocessed BRK Transseptal Needle approved by the FDA?

Reprocessed BRK Transseptal Needle received FDA 510(k) clearance on 2020-07-22, under approval number K192998.

What company makes Reprocessed BRK Transseptal Needle?

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

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

The FDA product code for Reprocessed BRK Transseptal Needle is NMK.

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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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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