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FDA 510(k)

MONARCH(TM) INFLATION SYRINGE

K-Number: K913994 · 1992-02-04

ApplicantMerit Medical Systems, Inc.
Decision Date1992-02-04
Product CodeMAV
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MONARCH(TM) INFLATION 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 1992-02-04 under 510(k) number K913994. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONARCH(TM) INFLATION SYRINGE?

MONARCH(TM) INFLATION SYRINGE is a medical device that received FDA 510(k) clearance on 1992-02-04. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K913994.

When did MONARCH(TM) INFLATION SYRINGE receive FDA 510(k) clearance?

MONARCH(TM) INFLATION SYRINGE received FDA 510(k) clearance on 1992-02-04, under 510(k) number K913994.

Who is the listed applicant for MONARCH(TM) INFLATION 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(TM) INFLATION SYRINGE?

The FDA product code for MONARCH(TM) INFLATION SYRINGE is MAV.

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Related Devices (Code: MAV)

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.

K260035Digital Indeflator INFLANTEUAB TelemedicinaK220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)Medtronic VascularK162272Fluent inflation deviceVascular Solutions, Inc.K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival KitMedtronic, Inc.K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc.K130566BASIXTOUCHMerit Medical Systems, 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.

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