Cleared Traditional

K203067 - Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F (FDA 510(k) Clearance)

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

K203067 · Qura S.R.L · Cardiovascular device

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Nov 2021

Decision

395d

Days

Class 2

Risk

K203067 is an FDA 510(k) clearance for the Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cann.... Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Qura S.R.L (Mirandola, IT). The FDA issued a Cleared decision on November 8, 2021 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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. Elevated predicate reliance profile. 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 Qura S.R.L devices

Submission Details

510(k) Number	K203067 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 09, 2020
Decision Date	November 08, 2021
Days to Decision	395 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

270d slower than avg

Panel avg: 125d · This submission: 395d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.4210

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.