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FDA 510(k)

Reprocessed IntellaMap Orion High Resolution Mapping Catheter

K-Number: K211662 · 2021-11-18

ApplicantInnovative Health, LLC
Decision Date2021-11-18
Product CodeNLG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed IntellaMap Orion High Resolution Mapping Catheter 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 2021-11-18 under 510(k) number K211662. The device is classified under product code NLG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed IntellaMap Orion High Resolution Mapping Catheter?

Reprocessed IntellaMap Orion High Resolution Mapping Catheter is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Innovative Health, LLC. The 510(k) number is K211662.

When did Reprocessed IntellaMap Orion High Resolution Mapping Catheter receive FDA 510(k) clearance?

Reprocessed IntellaMap Orion High Resolution Mapping Catheter received FDA 510(k) clearance on 2021-11-18, under 510(k) number K211662.

Who is the listed applicant for Reprocessed IntellaMap Orion High Resolution Mapping Catheter?

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 IntellaMap Orion High Resolution Mapping Catheter?

The FDA product code for Reprocessed IntellaMap Orion High Resolution Mapping Catheter is NLG.

Related Clinical Trials

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Related Devices (Code: NLG)

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.

K212776Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLCK190785Reprocessed PentaRay Nav eco High-Density Mapping CatheterInnovative 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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