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FDA 510(k)

MEDRAD Mark 7 Arterion Injection System

K-Number: K193028 · 2019-12-05

ApplicantBayer Medical Care, Inc.
Decision Date2019-12-05
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDRAD Mark 7 Arterion Injection System is a medical device manufactured by Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2019-12-05 under approval number K193028. 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 MEDRAD Mark 7 Arterion Injection System?

MEDRAD Mark 7 Arterion Injection System is a medical device that received FDA 510(k) clearance on 2019-12-05. It is manufactured by Bayer Medical Care, Inc.. The 510(k) number is K193028.

When was MEDRAD Mark 7 Arterion Injection System approved by the FDA?

MEDRAD Mark 7 Arterion Injection System received FDA 510(k) clearance on 2019-12-05, under approval number K193028.

What company makes MEDRAD Mark 7 Arterion Injection System?

MEDRAD Mark 7 Arterion Injection System is manufactured by Bayer Medical Care, Inc..

What is the FDA product code for MEDRAD Mark 7 Arterion Injection System?

The FDA product code for MEDRAD Mark 7 Arterion Injection System is DXT.

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Other Devices by Bayer Medical Care, Inc.

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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.

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