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FDA 510(k)

VAMP Plus Venous/Arterial Blood Management Protection System

K-Number: K181684 · 2018-11-08

ApplicantEdwards Lifesciences, LLC
Decision Date2018-11-08
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VAMP Plus Venous/Arterial Blood Management Protection System is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2018-11-08 under approval number K181684. 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 Plus Venous/Arterial Blood Management Protection System?

VAMP Plus Venous/Arterial Blood Management Protection System is a medical device that received FDA 510(k) clearance on 2018-11-08. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K181684.

When was VAMP Plus Venous/Arterial Blood Management Protection System approved by the FDA?

VAMP Plus Venous/Arterial Blood Management Protection System received FDA 510(k) clearance on 2018-11-08, under approval number K181684.

What company makes VAMP Plus Venous/Arterial Blood Management Protection System?

VAMP Plus Venous/Arterial Blood Management Protection System is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for VAMP Plus Venous/Arterial Blood Management Protection System?

The FDA product code for VAMP Plus Venous/Arterial Blood Management Protection System is KRA.

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Related PubMed Literature

PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026) 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) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40246726 [Brief Discussion on the General Requirements of Quality Management System of Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Edwards Lifesciences, LLC

K161962VAMP Venous/Arterial Blood Management Protection System K160645PreSep Oligon Oximetry Catheter K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform K160084Swan Ganz Catheters K152980Flo Trac sensor, Volume View sensor K172660Duravess bovine pericardial vascular patch

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Related Devices (Code: KRA)

K161962VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC K160884CXI Support CatheterCook Incorporated K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc. K161402Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. K161801CrossCath Support CatheterCook Incorporated K153501Bullfrog Micro-Infusion DeviceMercator Medsystems, 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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