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FDA 510(k)

Reprocesses Umbilical Cable

K-Number: K221854 · 2022-08-06

ApplicantInnovative Health, LLC
Decision Date2022-08-06
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocesses Umbilical Cable is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2022-08-06 under approval number K221854. 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 Reprocesses Umbilical Cable?

Reprocesses Umbilical Cable is a medical device that received FDA 510(k) clearance on 2022-08-06. It is manufactured by Innovative Health, LLC. The 510(k) number is K221854.

When was Reprocesses Umbilical Cable approved by the FDA?

Reprocesses Umbilical Cable received FDA 510(k) clearance on 2022-08-06, under approval number K221854.

What company makes Reprocesses Umbilical Cable?

Reprocesses Umbilical Cable is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocesses Umbilical Cable?

The FDA product code for Reprocesses Umbilical Cable is NLH.

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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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