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FDA 510(k)

MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE

K-Number: K940896 · 1994-08-11

ApplicantMedex, Inc.
Decision Date1994-08-11
Product CodeMAV
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medex, Inc.. It received FDA 510(k) clearance on 1994-08-11 under 510(k) number K940896. 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 MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE?

MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE is a medical device that received FDA 510(k) clearance on 1994-08-11. The listed applicant is Medex, Inc.. The 510(k) number is K940896.

When did MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE receive FDA 510(k) clearance?

MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE received FDA 510(k) clearance on 1994-08-11, under 510(k) number K940896.

Who is the listed applicant for MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE?

The FDA 510(k) record lists Medex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE?

The FDA product code for MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE is MAV.

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Other records listing Medex, Inc. as applicant

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K042432PHARMGUARD TOOLBOX, MODEL G6000782K040899MEDEX 3000 SERIES MR SYRINGE INFUSION PUMPK020780TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICPK000328MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMPK982640MEDEX 3000 SERIES SYRINGE INFUSION PUMPK982123CONTRAST CONTROL DEVICE

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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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