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FDA 510(k)

VAMP Optima closed blood sampling system

K-Number: K180275 · 2018-10-24

ApplicantEdwards Lifesciences, LLC
Decision Date2018-10-24
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VAMP Optima closed blood sampling system is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2018-10-24 under approval number K180275. 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 Optima closed blood sampling system?

VAMP Optima closed blood sampling system is a medical device that received FDA 510(k) clearance on 2018-10-24. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K180275.

When was VAMP Optima closed blood sampling system approved by the FDA?

VAMP Optima closed blood sampling system received FDA 510(k) clearance on 2018-10-24, under approval number K180275.

What company makes VAMP Optima closed blood sampling system?

VAMP Optima closed blood sampling system is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for VAMP Optima closed blood sampling system?

The FDA product code for VAMP Optima closed blood sampling system is KRA.

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

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Related Devices (Code: 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.

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