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FDA 510(k)

Reprocessed Supreme Diagnostic Electrophysiology Catheters

K-Number: K161769 · 2016-12-06

ApplicantInnovative Health, LLC
Decision Date2016-12-06
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Supreme Diagnostic Electrophysiology Catheters is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2016-12-06 under approval number K161769. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Supreme Diagnostic Electrophysiology Catheters?

Reprocessed Supreme Diagnostic Electrophysiology Catheters is a medical device that received FDA 510(k) clearance on 2016-12-06. It is manufactured by Innovative Health, LLC. The 510(k) number is K161769.

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

Reprocessed Supreme Diagnostic Electrophysiology Catheters received FDA 510(k) clearance on 2016-12-06, under approval number K161769.

What company makes Reprocessed Supreme Diagnostic Electrophysiology Catheters?

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

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

The FDA product code for Reprocessed Supreme Diagnostic Electrophysiology Catheters is DRF.

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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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