FDA 510(k)

MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE

K-Number: K083523 · 2009-02-04

Decision Date2009-02-04

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING 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 2009-02-04 under 510(k) number K083523. 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 MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE?

MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE is a medical device that received FDA 510(k) clearance on 2009-02-04. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K083523.

When did MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE receive FDA 510(k) clearance?

MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE received FDA 510(k) clearance on 2009-02-04, under 510(k) number K083523.

Who is the listed applicant for MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING 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 MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE?

The FDA product code for MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Merit Medical Systems, Inc. as applicant

K261310FlexTract Deflectable-Rotational Dilator Sheath Set K262086PreludeSYNC™ Radial Compression Device K254073StatSeal Disc K251802STAR RF Ablation System K252892SCOUT MD Surgical Guidance System K250853Merit Syringe

View all 159 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 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.K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableAcist 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.