Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Balt USA, LLC. It received FDA 510(k) clearance on 2025-05-30 under 510(k) 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. The listed applicant is Balt USA, LLC. The 510(k) number is K251383.

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

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

Who is the listed applicant for Prestige Coil System (Prestige Packing Line Extension)?

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

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.

Related Clinical Trials

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.

NCT04410146The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)COMPLETEDNCT07225075Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)RECRUITING

Other records listing Balt USA, 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.

K260199SLIM MicrocatheterK254223Next Generation 088 CatheterPMA P250009Neurovascular Liquid Embolic AgentK254221Optima Coil System (OptiOne Coil System)K252569Carrier XL Delivery CatheterK252700Optima Coil System (Optima Packing Coil System)

View all 20 devices →

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 CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

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.

↑