FDA 510(k)

VAMP Plus Venous/Arterial Blood Management Protection System

K-Number: K181684 · 2018-11-08

Decision Date2018-11-08

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VAMP Plus Venous/Arterial Blood Management Protection System is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2018-11-08 under 510(k) 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. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K181684.

When did VAMP Plus Venous/Arterial Blood Management Protection System receive FDA 510(k) clearance?

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

Who is the listed applicant for VAMP Plus Venous/Arterial Blood Management Protection System?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: KRA)

K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation K250794InVera Infusion DeviceInvera Medical K243534Micro CatheterSuzhou Zenith Vascular SciTech Limited K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)Transit Scientific, LLC K231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, 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.