Cleared Traditional

K994171 - MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE

K994171 is an FDA 510(k) clearance for MEDTRONIC AORTOCORONARY SHUNT AND SEPAR..., manufactured by Medtronic Cardiac Surgical Products. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K994171 · Medtronic Cardiac Surgical Products · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
139d
Days
Class 2
Risk

K994171 is an FDA 510(k) clearance for the MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medtronic Cardiac Surgical Products (Grand Rapids, US). The FDA issued a Cleared decision on April 27, 2000 after a review of 139 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Cardiac Surgical Products devices

FDA 510(k) Submission Details - K994171

510(k) Number K994171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1999
Decision Date April 27, 2000
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
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 330
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K994171.
STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP
K994209 · Cobe Cardiovascular, Inc. · Jun 2000
CIPA (ADULTS) CIPI (INFANTS)
K992932 · Dmc Medical, Ltd. · Jun 2000
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP
K994243 · Heartport, Inc. · May 2000
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT
K993677 · Medtronic Vascular · Apr 2000
ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE
K993818 · California Medical Laboratories, Inc. · Feb 2000
A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44
K991541 · A-Med Systems, Inc. · Dec 1999