Cleared Special

K990514 - MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR

K990514 is an FDA 510(k) clearance for MODIFICATION OF BARD QUANTUM CVR, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DTP cleared through the Special 510(k) pathway after a 19-day FDA review.

K990514 · C.R. Bard, Inc. · Cardiovascular device
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Mar 1999
Decision
19d
Days
Class 2
Risk

K990514 is an FDA 510(k) clearance for the MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR. 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 March 9, 1999 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4230 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K990514

510(k) Number K990514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1999
Decision Date March 09, 1999
Days to Decision 19 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 125d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

DTP Device Classification - Class 2, Special Controls

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 K990514.
VENOUS BUBBLE TRAP, MODEL VBT 160
K082412 · Mapquet Cardiopulmonary AG · Nov 2008
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K004046 · Cobe Cardiovascular, Inc. · Apr 2001
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K002591 · Cobe Cardiovascular, Inc. · Sep 2000
DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
K984322 · Dideco S.P.A. · Mar 1999
BARD QUANTUM CVR
K962726 · C.R. Bard, Inc. · Oct 1996
SARNS FILTERED VENOUS RESERVIOR MODIFICATION
K941654 · 3M Health Care, Sarns · Jul 1994
K990514 · MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
Download PDF C.R. Bard, Inc.