Cleared Special

MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR

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

About This 510(k) Submission

K990514 is an FDA 510(k) clearance for the MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR, a Defoamer, Cardiopulmonary Bypass (Class II — Special Controls, product code DTP), submitted by C.R. Bard, Inc. (Haverhill, US). The FDA issued a Cleared decision on March 9, 1999, 19 days after receiving the submission on February 18, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4230.

Submission Details

510(k) Number K990514 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DTP — Defoamer, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4230

Similar Devices — DTP Defoamer, Cardiopulmonary Bypass

All 33
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
K101186 · Medtronic Perfusion Systems · Sep 2010
VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-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

More from C.R. Bard, Inc.

View all
Rubber Utility Catheter
K251864 · KOD · Feb 2026
Bard? Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
K251186 · LDF · May 2025
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH? Temporary Pacing Electrode Catheter,
K241334 · LDF · Jan 2025
Aspirex? Thrombectomy System
K230356 · QEW · Mar 2023
Highlander? 014 PTA Balloon Dilatation Catheter
K223177 · LIT · Jan 2023