Cleared Traditional

K981628 - BARD QUANTUM SVR MODEL NUMBER H-6440VR

K981628 is an FDA 510(k) clearance for BARD QUANTUM SVR MODEL NUMBER H-6440VR, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K981628 · C.R. Bard, Inc. · Cardiovascular device
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Aug 1998
Decision
90d
Days
Class 2
Risk

K981628 is an FDA 510(k) clearance for the BARD QUANTUM SVR MODEL NUMBER H-6440VR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Haverhill, US). The FDA issued a Cleared decision on August 5, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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

FDA 510(k) Submission Details - K981628

510(k) Number K981628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1998
Decision Date August 05, 1998
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 146
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K981628.
CAPIOX SX HARDSHELL RESEVOIR
K982223 · Terumo Medical Corp. · Sep 1998
COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800
K980786 · Cobe Cardiovascular, Inc. · Aug 1998
BETTER-BLADDER (BB)
K981284 · Circulatory Technology, Inc. · Aug 1998
CAPIOX SX HARDSHELL RESERVOIR
K980935 · Terumo Medical Corp. · May 1998
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
K974155 · Baxter Healthcare Corp · Jan 1998
CHASE TEMPERATURE PROBE
K971013 · Chase Medical, Inc. · Oct 1997