Cleared Traditional

K181684 - VAMP Plus Venous/Arterial Blood Management Protection System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 172
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