FDA 510(k)

Merit Coronary Control Syringe

K-Number: K163084 · 2017-06-15

Decision Date2017-06-15

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Merit Coronary Control Syringe 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 2017-06-15 under 510(k) number K163084. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Merit Coronary Control Syringe?

Merit Coronary Control Syringe is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K163084.

When did Merit Coronary Control Syringe receive FDA 510(k) clearance?

Merit Coronary Control Syringe received FDA 510(k) clearance on 2017-06-15, under 510(k) number K163084.

Who is the listed applicant for Merit Coronary Control Syringe?

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 Merit Coronary Control Syringe?

The FDA product code for Merit Coronary Control Syringe is DXT.

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_RECRUITING NCT04540302The Merit WRAPSODY AV Access Efficacy Study (WAVE)COMPLETED NCT05050799US Post-Market Surveillance Study of the Surfacer SystemRECRUITING NCT06153667Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)RECRUITING NCT06422871PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on HemodialysisRECRUITING NCT06587282PREEMIE: Study for Treatment of PDA in Premature InfantsACTIVE_NOT_RECRUITING

Other records listing Merit Medical Systems, Inc. as applicant

K261310FlexTract Deflectable-Rotational Dilator Sheath Set K262086PreludeSYNC™ Radial Compression Device PMA P240023System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment K254073StatSeal Disc K251802STAR RF Ablation System K252892SCOUT MD Surgical Guidance System

View all 68 devices →

Related Devices (Code: DXT)

K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable SyrFortis Biosolutions Company Limited K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableAcist Medical Systems, Inc.K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)Acist Medical Systems, Inc.K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, 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.