FDA 510(k)

Prestige Coil System

K-Number: K220699 · 2022-04-08

Decision Date2022-04-08

Product CodeKRD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Prestige Coil System is the device name listed in this FDA 510(k) record. The listed applicant is Bait USA, LLC. It received FDA 510(k) clearance on 2022-04-08 under 510(k) 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. The listed applicant is Bait USA, LLC. The 510(k) number is K220699.

When did Prestige Coil System receive FDA 510(k) clearance?

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

Who is the listed applicant for Prestige Coil System?

The FDA 510(k) record lists Bait USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prestige Coil System?

The FDA product code for Prestige Coil System is KRD.

Related Devices (Code: KRD)

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.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation K261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.