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FDA 510(k)

Reprocessed Polaris X Steerable Diagnostic EP Catheter

K-Number: K160303 · 2016-05-10

ApplicantInnovative Health, LLC
Decision Date2016-05-10
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Polaris X Steerable Diagnostic EP Catheter is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2016-05-10 under approval number K160303. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Polaris X Steerable Diagnostic EP Catheter?

Reprocessed Polaris X Steerable Diagnostic EP Catheter is a medical device that received FDA 510(k) clearance on 2016-05-10. It is manufactured by Innovative Health, LLC. The 510(k) number is K160303.

When was Reprocessed Polaris X Steerable Diagnostic EP Catheter approved by the FDA?

Reprocessed Polaris X Steerable Diagnostic EP Catheter received FDA 510(k) clearance on 2016-05-10, under approval number K160303.

What company makes Reprocessed Polaris X Steerable Diagnostic EP Catheter?

Reprocessed Polaris X Steerable Diagnostic EP Catheter is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Polaris X Steerable Diagnostic EP Catheter?

The FDA product code for Reprocessed Polaris X Steerable Diagnostic EP Catheter is NLH.

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Other Devices by Innovative Health, LLC

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Related Devices (Code: NLH)

K162251Reprocessed Viking Diagnostic Electrophysiology CathetersInnovative Health, LLC K161827Reprocessed Response Diagnostic Electrophysiology CathetersInnovative Health, LLC K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP CatheterInnovative Health, LLC K161393Reprocessed Orbiter ST Steerable Diagnostic EP CatheterInnovative Health, LLC K161464Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology CathetersInnovative Health, LLC K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterSterilmed, Inc.

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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