Cleared Traditional

K990396 - T-ANASTAFLO

K990396 is an FDA 510(k) clearance for T-ANASTAFLO, manufactured by Edwards Lifesciences Research Medical. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K990396 · Edwards Lifesciences Research Medical · Cardiovascular device
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Oct 1999
Decision
234d
Days
Class 2
Risk

K990396 is an FDA 510(k) clearance for the T-ANASTAFLO. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Edwards Lifesciences Research Medical (Midvale, US). The FDA issued a Cleared decision on October 1, 1999 after a review of 234 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 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 Edwards Lifesciences Research Medical devices

FDA 510(k) Submission Details - K990396

510(k) Number K990396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1999
Decision Date October 01, 1999
Days to Decision 234 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
109d slower than avg
Panel avg: 125d · This submission: 234d
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 329
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K990396.
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT
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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
MADTRONIC DLP ARTERIAL CANNULAE
K991066 · Medtronic Vascular · Sep 1999
VOYAGER QUAD CANNULA
K983270 · Cardiothoracic Systems, Inc. · Jul 1999
RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014
K991170 · Edwards Lifesciences Research Medical · Jul 1999