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FDA 510(k)

PreludeSYNC™ Radial Compression Device

K-Number: K262086 · 2026-07-22

ApplicantMerit Medical Systems, Inc.
Decision Date2026-07-22
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PreludeSYNC™ Radial Compression Device is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-07-22 under 510(k) number K262086. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PreludeSYNC™ Radial Compression Device?

PreludeSYNC™ Radial Compression Device is a medical device that received FDA 510(k) clearance on 2026-07-22. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K262086.

When did PreludeSYNC™ Radial Compression Device receive FDA 510(k) clearance?

PreludeSYNC™ Radial Compression Device received FDA 510(k) clearance on 2026-07-22, under 510(k) number K262086.

Who is the listed applicant for PreludeSYNC™ Radial Compression Device?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PreludeSYNC™ Radial Compression Device?

The FDA product code for PreludeSYNC™ Radial Compression Device is DXC.

Related Clinical Trials

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Other records listing Merit Medical Systems, Inc. as applicant

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Related Devices (Code: DXC)

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.

K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LPK232577Radial Compression DeviceNingbo Dizegens Medical Science Co.,Ltd

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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