Cleared Traditional

COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (K004046) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K004046 · Cobe Cardiovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
118d
Days
Class 2
Risk

K004046 is an FDA 510(k) clearance for the COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTE.... Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on April 26, 2001 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4230 - 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 Cobe Cardiovascular, Inc. devices

Submission Details

510(k) Number K004046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2000
Decision Date April 26, 2001
Days to Decision 118 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTP Defoamer, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4230
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 - DTP Defoamer, Cardiopulmonary Bypass

All 13
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K004046.
MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
K990514 · C.R. Bard, Inc. · Mar 1999
BARD QUANTUM CVR
K962726 · C.R. Bard, Inc. · Oct 1996
MAXIMA FILTERED HARDSHELL RESERVIOR
K933496 · Medtronic Vascular · Oct 1993
MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT
K911789 · Medtronic Vascular · Aug 1991
MODEL 5866-46 SLEEVE KIT
K910568 · Medtronic Vascular · Apr 1991
BARD FILTERED CARDIOTOMY RESERVOIR
K902856 · C.R. Bard, Inc. · Sep 1990