Cleared Special

RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE)

K030696 · Medtronic Perfusion Systems · Cardiovascular
Apr 2003
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K030696 is an FDA 510(k) clearance for the RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE), a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Medtronic Perfusion Systems (Brooklyn Park, US). The FDA issued a Cleared decision on April 11, 2003, 36 days after receiving the submission on March 6, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number K030696 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2003
Decision Date April 11, 2003
Days to Decision 36 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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

Similar Devices — DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 399
Venous Return Cannulae
K250937 · LivaNova USA, Inc. · Mar 2026
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
K260043 · Smart Reactors · Feb 2026
Retrograde Coronary Sinus Perfusion Cannulae
K253203 · Medtronic, Inc. · Feb 2026
Dual Stage Venous Cannulae
K253671 · Sorin Group Italia S.R.L. · Jan 2026
Clearview Intracoronary Shunts
K253998 · Medtronic, Inc. · Jan 2026
AngioVac Cannula
K253106 · AngioDynamics, Inc. · Oct 2025

More from Medtronic Perfusion Systems

View all
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)
K240666 · DTZ · Jul 2024
autoLog IQ Autotransfusion System
K181954 · CAC · Aug 2018
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
K123351 · DTM · Mar 2013
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
K101186 · DTP · Sep 2010
MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD
K090869 · DWF · Aug 2009