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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2016-11-28 under 510(k) 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. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K161962.

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

VAMP Venous/Arterial Blood Management Protection System received FDA 510(k) clearance on 2016-11-28, under 510(k) number K161962.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITINGNCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITINGNCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITINGNCT03745313Edwards CLASP TR EFSCOMPLETEDNCT04097145Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical TrialRECRUITINGNCT04614402Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair SystemACTIVE_NOT_RECRUITING

Other records listing Edwards Lifesciences, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P860057replacement Heart-valvePMA P250019Prosthesis, mitral valve, percutaneously deliveredPMA P230013Percutaneously Delivered Prostheses and Tricuspid ValvesPMA P220003Mitral valve repair devicesPMA P200015Pulmonary valve prosthesis percutaneously deliveredPMA P150048heart-valve, non-allograft tissue

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Related Devices (Code: KRA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech LimitedK231821XO 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, LLCK231279Peregrine 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.

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