CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set
K-Number: K151048 · 2016-01-22
ApplicantBracco Injeneering
Decision Date2016-01-22
Product CodeIZQ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set is a medical device manufactured by Bracco Injeneering. It received FDA 510(k) clearance on 2016-01-22 under approval number K151048. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set?
CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set is a medical device that received FDA 510(k) clearance on 2016-01-22. It is manufactured by Bracco Injeneering. The 510(k) number is K151048.
When was CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set approved by the FDA?
CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set received FDA 510(k) clearance on 2016-01-22, under approval number K151048.
What company makes CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set?
CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set is manufactured by Bracco Injeneering.
What is the FDA product code for CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set?
The FDA product code for CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set is IZQ.
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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.