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FDA 510(k)

Reprocessed Viking Diagnostic Electrophysiology Catheters

K-Number: K162251 · 2016-12-21

ApplicantInnovative Health, LLC
Decision Date2016-12-21
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Viking Diagnostic Electrophysiology Catheters is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2016-12-21 under approval number K162251. 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 Viking Diagnostic Electrophysiology Catheters?

Reprocessed Viking Diagnostic Electrophysiology Catheters is a medical device that received FDA 510(k) clearance on 2016-12-21. It is manufactured by Innovative Health, LLC. The 510(k) number is K162251.

When was Reprocessed Viking Diagnostic Electrophysiology Catheters approved by the FDA?

Reprocessed Viking Diagnostic Electrophysiology Catheters received FDA 510(k) clearance on 2016-12-21, under approval number K162251.

What company makes Reprocessed Viking Diagnostic Electrophysiology Catheters?

Reprocessed Viking Diagnostic Electrophysiology Catheters is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Viking Diagnostic Electrophysiology Catheters?

The FDA product code for Reprocessed Viking Diagnostic Electrophysiology Catheters is NLH.

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Related Devices (Code: NLH)

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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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