Cleared Traditional

K971669 - COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR

K971669 is an FDA 510(k) clearance for COBE HVR 4000 FILTERED AND NONFILTERED ..., manufactured by Cobe Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K971669 · Cobe Cardiovascular, Inc. · Cardiovascular device
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Jul 1997
Decision
78d
Days
Class 2
Risk

K971669 is an FDA 510(k) clearance for the COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on July 23, 1997 after a review of 78 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cobe Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K971669

510(k) Number K971669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1997
Decision Date July 23, 1997
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
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 151
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K971669.
BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)
K972017 · Minntech Corp. · Sep 1997
VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
K964908 · Sorin Biomedical, Inc. · Sep 1997
VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT
K964907 · Sorin Biomedical, Inc. · Aug 1997
MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM
K971105 · Avecor Cardiovascular, Inc. · Jul 1997
GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR
K964973 · Gish Biomedical, Inc. · Mar 1997
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
K961836 · Medtronic Vascular · Nov 1996