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FDA 510(k)

Prestige Coil System (Prestige Packing Line Extension)

K-Number: K251383 · 2025-05-30

ApplicantBalt USA, LLC
Decision Date2025-05-30
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Prestige Coil System (Prestige Packing Line Extension) is a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2025-05-30 under approval number K251383. 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 Packing Line Extension)?

Prestige Coil System (Prestige Packing Line Extension) is a medical device that received FDA 510(k) clearance on 2025-05-30. It is manufactured by Balt USA, LLC. The 510(k) number is K251383.

When was Prestige Coil System (Prestige Packing Line Extension) approved by the FDA?

Prestige Coil System (Prestige Packing Line Extension) received FDA 510(k) clearance on 2025-05-30, under approval number K251383.

What company makes Prestige Coil System (Prestige Packing Line Extension)?

Prestige Coil System (Prestige Packing Line Extension) is manufactured by Balt USA, LLC.

What is the FDA product code for Prestige Coil System (Prestige Packing Line Extension)?

The FDA product code for Prestige Coil System (Prestige Packing Line Extension) 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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