Cleared Abbreviated

K023622 - STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35

K023622 is an FDA 510(k) clearance for STOCKERT PEDIATRIC AORTIC CANNULAE, manufactured by Stockert Instrumente GmbH. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Abbreviated 510(k) pathway after a 23-day FDA review.

K023622 · Stockert Instrumente GmbH · Cardiovascular device
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Nov 2002
Decision
23d
Days
Class 2
Risk

K023622 is an FDA 510(k) clearance for the STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Stockert Instrumente GmbH (Morrison, US). The FDA issued a Cleared decision on November 21, 2002 after a review of 23 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Stockert Instrumente GmbH devices

FDA 510(k) Submission Details - K023622

510(k) Number K023622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2002
Decision Date November 21, 2002
Days to Decision 23 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
Pathway characteristics
Standards-based clearance path.

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 322
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K023622.
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
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
K012538 · Medtronic Vascular · Aug 2001