Cleared Traditional

BARD QUANTUM CVR (K962726) - FDA 510(k) Clearance

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

K962726 · C.R. Bard, Inc. · Cardiovascular device
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Oct 1996
Decision
107d
Days
Class 2
Risk

K962726 is an FDA 510(k) clearance for the BARD QUANTUM CVR. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Haverhill, US). The FDA issued a Cleared decision on October 30, 1996 after a review of 107 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K962726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1996
Decision Date October 30, 1996
Days to Decision 107 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
18d faster than avg
Panel avg: 125d · This submission: 107d
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 33
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K962726.
MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
K990514 · C.R. Bard, Inc. · Mar 1999
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
MCR4000 & MCR4000F CARDIOTOMY RESERVOIR
K902355 · Medtronic Vascular · Aug 1990