Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ecomed Disposable Angiographic Syringes

K-Number: K162088 · 2017-01-27

ApplicantEcomed Solutions, LLC
Decision Date2017-01-27
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ecomed Disposable Angiographic Syringes is a medical device manufactured by Ecomed Solutions, LLC. It received FDA 510(k) clearance on 2017-01-27 under approval number K162088. 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 Ecomed Disposable Angiographic Syringes?

Ecomed Disposable Angiographic Syringes is a medical device that received FDA 510(k) clearance on 2017-01-27. It is manufactured by Ecomed Solutions, LLC. The 510(k) number is K162088.

When was Ecomed Disposable Angiographic Syringes approved by the FDA?

Ecomed Disposable Angiographic Syringes received FDA 510(k) clearance on 2017-01-27, under approval number K162088.

What company makes Ecomed Disposable Angiographic Syringes?

Ecomed Disposable Angiographic Syringes is manufactured by Ecomed Solutions, LLC.

What is the FDA product code for Ecomed Disposable Angiographic Syringes?

The FDA product code for Ecomed Disposable Angiographic Syringes is DXT.

Other Devices by Ecomed Solutions, LLC

K234129Ecomed Disposable Administration Sets

Related Devices (Code: DXT)

K152906Disposable High Pressure Injector SyringeWuxi Yushou Medical Appliances Co., Ltd. K160190Sunmed Control SyringesSunny Medical Device (Shenzhen) Co., Ltd. K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc. K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. K160107DiamondTOUCH Inflation Device and Fluid Dispensing SyringeMerit Medical Systems, Inc. K152978DeRoyal Angiography KitsDeroyal Industries, 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.

↑