VAMP Venous/Arterial Blood Management Protection System
K-Number: K161962 · 2016-11-28
ApplicantEdwards Lifesciences, LLC
Decision Date2016-11-28
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
VAMP Venous/Arterial Blood Management Protection System is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2016-11-28 under approval number K161962. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VAMP Venous/Arterial Blood Management Protection System?
VAMP Venous/Arterial Blood Management Protection System is a medical device that received FDA 510(k) clearance on 2016-11-28. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K161962.
When was VAMP Venous/Arterial Blood Management Protection System approved by the FDA?
VAMP Venous/Arterial Blood Management Protection System received FDA 510(k) clearance on 2016-11-28, under approval number K161962.
What company makes VAMP Venous/Arterial Blood Management Protection System?
VAMP Venous/Arterial Blood Management Protection System is manufactured by Edwards Lifesciences, LLC.
What is the FDA product code for VAMP Venous/Arterial Blood Management Protection System?
The FDA product code for VAMP Venous/Arterial Blood Management Protection System is KRA.
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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.