Decision Date2016-12-21
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Reprocessed Viking Diagnostic Electrophysiology Catheters 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 2016-12-21 under 510(k) 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. The listed applicant is Innovative Health, LLC. The 510(k) number is K162251.
When did Reprocessed Viking Diagnostic Electrophysiology Catheters receive FDA 510(k) clearance?
Reprocessed Viking Diagnostic Electrophysiology Catheters received FDA 510(k) clearance on 2016-12-21, under 510(k) number K162251.
Who is the listed applicant for Reprocessed Viking Diagnostic Electrophysiology Catheters?
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 Viking Diagnostic Electrophysiology Catheters?
The FDA product code for Reprocessed Viking Diagnostic Electrophysiology Catheters is NLH.
Other records listing Innovative Health, LLC as applicant
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.
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Related Devices (Code: NLH)
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.
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Official Source
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