Cleared Abbreviated

K002273 - STOCKERT A272 SERIES PEDIATRIC AORTIC C...

K002273 is the FDA 510(k) clearance for STOCKERT A272 SERIES PEDIATRIC AORTIC C... by Stoeckert Instrumente. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Abbreviated 510(k) pathway after a 187-day FDA review.

K002273 · Stoeckert Instrumente · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
187d
Days
Class 2
Risk

K002273 is an FDA 510(k) clearance for the STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Stoeckert Instrumente (Arvada, US). The FDA issued a Cleared decision on January 29, 2001 after a review of 187 days - an extended review 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 Stoeckert Instrumente devices

Submission Details

510(k) Number K002273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2000
Decision Date January 29, 2001
Days to Decision 187 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
62d slower than avg
Panel avg: 125d · This submission: 187d
Pathway characteristics
Standards-based clearance path.

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.

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

All 254
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K002273.
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
K012538 · Medtronic Vascular · Aug 2001
RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET
K010974 · Sorin Group Italia S.R.L. · Jun 2001
RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET
K002019 · Sorin Group Italia S.R.L. · Mar 2001
QUEST MPS BACK-UP SYSYEM
K002366 · Quest Medical, Inc. · Sep 2000
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB
K001565 · Edwards Lifesciences, LLC · Aug 2000
STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP
K994209 · Cobe Cardiovascular, Inc. · Jun 2000