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FDA 510(k)

Low Profile Companion Sheath

K-Number: K223872 · 2023-01-19

ApplicantMerit Medical Systems, Inc.
Decision Date2023-01-19
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Low Profile Companion Sheath 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 2023-01-19 under 510(k) number K223872. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Low Profile Companion Sheath?

Low Profile Companion Sheath is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K223872.

When did Low Profile Companion Sheath receive FDA 510(k) clearance?

Low Profile Companion Sheath received FDA 510(k) clearance on 2023-01-19, under 510(k) number K223872.

Who is the listed applicant for Low Profile Companion Sheath?

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 Low Profile Companion Sheath?

The FDA product code for Low Profile Companion Sheath is DYB.

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.

NCT03311451C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.ACTIVE_NOT_RECRUITINGNCT04540302The Merit WRAPSODY AV Access Efficacy Study (WAVE)COMPLETEDNCT05050799US Post-Market Surveillance Study of the Surfacer SystemRECRUITINGNCT06153667Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)RECRUITINGNCT06422871PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on HemodialysisRECRUITINGNCT06587282PREEMIE: Study for Treatment of PDA in Premature InfantsACTIVE_NOT_RECRUITING

Other records listing Merit Medical Systems, Inc. as applicant

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Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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