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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 the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2020-07-22 under 510(k) 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. The listed applicant is Innovative Health, LLC. The 510(k) number is K192998.

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

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

Who is the listed applicant for Reprocessed BRK 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 BRK Transseptal Needle?

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

Related Clinical Trials

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.

NCT06358391To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.RECRUITING

Other records listing Innovative Health, LLC as applicant

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.

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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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