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FDA 510(k)

Prestige Coil System

K-Number: K220699 · 2022-04-08

ApplicantBait USA, LLC
Decision Date2022-04-08
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Prestige Coil System is a medical device manufactured by Bait USA, LLC. It received FDA 510(k) clearance on 2022-04-08 under approval number K220699. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prestige Coil System?

Prestige Coil System is a medical device that received FDA 510(k) clearance on 2022-04-08. It is manufactured by Bait USA, LLC. The 510(k) number is K220699.

When was Prestige Coil System approved by the FDA?

Prestige Coil System received FDA 510(k) clearance on 2022-04-08, under approval number K220699.

What company makes Prestige Coil System?

Prestige Coil System is manufactured by Bait USA, LLC.

What is the FDA product code for Prestige Coil System?

The FDA product code for Prestige Coil System is KRD.

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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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