Cleared Traditional

K232480 - ProtekDuo Veno-Venous Cannula Sets (FDA 510(k) Clearance)

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

K232480 · Cardiacassist, Inc. · Cardiovascular device
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Oct 2023
Decision
51d
Days
Class 2
Risk

K232480 is an FDA 510(k) clearance for the ProtekDuo Veno-Venous Cannula Sets. Classified as Dual Lumen Ecmo Cannula (product code PZS), Class II - Special Controls.

Submitted by Cardiacassist, Inc. (Pittsburg, US). The FDA issued a Cleared decision on October 6, 2023 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4100 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardiacassist, Inc. devices

Submission Details

510(k) Number K232480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2023
Decision Date October 06, 2023
Days to Decision 51 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
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZS Dual Lumen Ecmo Cannula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4100
Definition Long Term Support Greater Than 6 Hours For Acute Respiratory Or Acute Cardiopulmonary Failure, Where Other Available Treatment Options Have Failed, And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent.
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.