Cleared Traditional

K181684 - VAMP Plus Venous/Arterial Blood Managem...

K181684 is an FDA 510(k) clearance for VAMP Plus Venous/Arterial Blood Managem..., manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K181684 · Edwards Lifesciences, LLC · Cardiovascular device
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Nov 2018
Decision
135d
Days
Class 2
Risk

K181684 is an FDA 510(k) clearance for the VAMP Plus Venous/Arterial Blood Management Protection System. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on November 8, 2018 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K181684

510(k) Number K181684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2018
Decision Date November 08, 2018
Days to Decision 135 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 125d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - KRA Catheter, Continuous Flush

All 130
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K181684.
TriSalus Infusion System
K193107 · Trisalus Life Sciences · Dec 2019
Instylla Microcatheter
K191731 · Instylla, Inc. · Aug 2019
Multi-Sideport Catheter Infusion Set
K182071 · Cook Incorporated · Apr 2019
VAMP Optima closed blood sampling system
K180275 · Edwards Lifesciences, LLC · Oct 2018
VAMP Venous/Arterial Blood Management Protection System
K173586 · Edwards Lifesciences, LLC · Apr 2018
Microcatheter and guide-wire system
K171665 · Suzhou Hengrui Disheng Medical Co., Ltd. · Jan 2018