FDA 510(k)

BASIXCONPAK ANALOG INFLATION SYRINGE

K-Number: K122321 · 2012-12-19

Decision Date2012-12-19

Product CodeMAV

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BASIXCONPAK ANALOG INFLATION SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Ireland, Ltd.. It received FDA 510(k) clearance on 2012-12-19 under 510(k) number K122321. 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 BASIXCONPAK ANALOG INFLATION SYRINGE?

BASIXCONPAK ANALOG INFLATION SYRINGE is a medical device that received FDA 510(k) clearance on 2012-12-19. The listed applicant is Merit Medical Ireland, Ltd.. The 510(k) number is K122321.

When did BASIXCONPAK ANALOG INFLATION SYRINGE receive FDA 510(k) clearance?

BASIXCONPAK ANALOG INFLATION SYRINGE received FDA 510(k) clearance on 2012-12-19, under 510(k) number K122321.

Who is the listed applicant for BASIXCONPAK ANALOG INFLATION SYRINGE?

The FDA 510(k) record lists Merit Medical Ireland, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BASIXCONPAK ANALOG INFLATION SYRINGE?

The FDA product code for BASIXCONPAK ANALOG INFLATION SYRINGE is MAV.

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Other records listing Merit Medical Ireland, Ltd. as applicant

K261640Merit MAK Nitinol/Gold-Tungsten Guide Wire K254137InQwire Amplatz Guide Wire K253847Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)K251385InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)K251181Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)

Related Devices (Code: MAV)

K260035Digital Indeflator INFLANTEUAB Telemedicina K220773Everest 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 Vascular K162272Fluent 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.