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FDA 510(k)

Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters

K-Number: K211276 · 2021-09-15

ApplicantInnovative Health, LLC
Decision Date2021-09-15
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2021-09-15 under approval number K211276. 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 Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters?

Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters is a medical device that received FDA 510(k) clearance on 2021-09-15. It is manufactured by Innovative Health, LLC. The 510(k) number is K211276.

When was Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters approved by the FDA?

Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters received FDA 510(k) clearance on 2021-09-15, under approval number K211276.

What company makes Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters?

Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters?

The FDA product code for Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters is NLH.

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Other Devices by Innovative Health, LLC

K162251Reprocessed Viking Diagnostic Electrophysiology Catheters K161827Reprocessed Response Diagnostic Electrophysiology Catheters K161769Reprocessed Supreme Diagnostic Electrophysiology Catheters K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter K161393Reprocessed Orbiter ST Steerable Diagnostic EP Catheter K161464Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters

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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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