Cleared Traditional

K023251 - PEDIATRIC ARTERIAL CANNULA

K023251 is an FDA 510(k) clearance for PEDIATRIC ARTERIAL CANNULA, manufactured by Polystan A/S. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K023251 · Polystan A/S · Cardiovascular device
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Dec 2002
Decision
65d
Days
Class 2
Risk

K023251 is an FDA 510(k) clearance for the PEDIATRIC ARTERIAL CANNULA. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Polystan A/S (Vaerlose, DK). The FDA issued a Cleared decision on December 4, 2002 after a review of 65 days - a notably fast clearance cycle.

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: 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 Polystan A/S devices

FDA 510(k) Submission Details - K023251

510(k) Number K023251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2002
Decision Date December 04, 2002
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 331
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K023251.
RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE)
K030696 · Medtronic Perfusion Systems · Apr 2003
ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106
K024069 · Medtronic Vascular · Jan 2003
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
K023880 · Ethicon, Inc. · Dec 2002
CIRCUIT TUBINGS WITH X-COATING
K023056 · Terumo Cardiovascular Systems Corp. · Nov 2002
AXILLARY ACCESS ARTERIAL CANNULA
K002578 · Edwards Lifesciences, LLC · Apr 2002
STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
K001509 · Cobe Cardiovascular, Inc. · Oct 2001