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FDA 510(k)

PreludeSYNC DISTAL Radial Compression System

K-Number: K180723 · 2018-04-17

ApplicantMerit Medical Systems, Inc.
Decision Date2018-04-17
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PreludeSYNC DISTAL Radial Compression System 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 2018-04-17 under 510(k) number K180723. 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 DISTAL Radial Compression System?

PreludeSYNC DISTAL Radial Compression System is a medical device that received FDA 510(k) clearance on 2018-04-17. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K180723.

When did PreludeSYNC DISTAL Radial Compression System receive FDA 510(k) clearance?

PreludeSYNC DISTAL Radial Compression System received FDA 510(k) clearance on 2018-04-17, under 510(k) number K180723.

Who is the listed applicant for PreludeSYNC DISTAL Radial Compression System?

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 DISTAL Radial Compression System?

The FDA product code for PreludeSYNC DISTAL Radial Compression System is DXC.

Related Clinical Trials

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Other records listing Merit Medical Systems, Inc. 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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetK262086PreludeSYNC™ Radial Compression DevicePMA P240023System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatmentK254073StatSeal DiscK251802STAR RF Ablation SystemK252892SCOUT MD Surgical Guidance System

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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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.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, LP

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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