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FDA 510(k)

MR Syringe Dual Pack for Solaris Injectors

K-Number: K161471 · 2016-10-06

ApplicantCoeur, Inc.
Decision Date2016-10-06
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MR Syringe Dual Pack for Solaris Injectors is a medical device manufactured by Coeur, Inc.. It received FDA 510(k) clearance on 2016-10-06 under approval number K161471. 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 MR Syringe Dual Pack for Solaris Injectors?

MR Syringe Dual Pack for Solaris Injectors is a medical device that received FDA 510(k) clearance on 2016-10-06. It is manufactured by Coeur, Inc.. The 510(k) number is K161471.

When was MR Syringe Dual Pack for Solaris Injectors approved by the FDA?

MR Syringe Dual Pack for Solaris Injectors received FDA 510(k) clearance on 2016-10-06, under approval number K161471.

What company makes MR Syringe Dual Pack for Solaris Injectors?

MR Syringe Dual Pack for Solaris Injectors is manufactured by Coeur, Inc..

What is the FDA product code for MR Syringe Dual Pack for Solaris Injectors?

The FDA product code for MR Syringe Dual Pack for Solaris Injectors is DXT.

Other Devices by Coeur, Inc.

K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip

Related Devices (Code: DXT)

K152906Disposable High Pressure Injector SyringeWuxi Yushou Medical Appliances Co., Ltd. K160190Sunmed Control SyringesSunny Medical Device (Shenzhen) Co., Ltd. K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. K160107DiamondTOUCH Inflation Device and Fluid Dispensing SyringeMerit Medical Systems, Inc. K152978DeRoyal Angiography KitsDeroyal Industries, Inc. K153141DyeVert Contrast Modulation SystemOsprey Medical, 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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