Cleared Traditional

K994389 - COBE HVR 2200 HARDSHELL VENOUS RESERVOIR

K994389 is an FDA 510(k) clearance for COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, 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 90-day FDA review.

K994389 · Cobe Cardiovascular, Inc. · Cardiovascular device
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Mar 2000
Decision
90d
Days
Class 2
Risk

K994389 is an FDA 510(k) clearance for the COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED. 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 March 27, 2000 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 Cobe Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K994389

510(k) Number K994389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1999
Decision Date March 27, 2000
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 134
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K994389.
CAPIOX RX HARDSHELL RESERVOIR
K013526 · Terumo Cardiovascular Systems Corp. · Nov 2001
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
K011864 · Medtronic Vascular · Jul 2001
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
K002238 · Terumo Cardiovascular Systems Corp. · Aug 2000
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED
K993001 · Cobe Cardiovascular, Inc. · Dec 1999
CAPIOX SX10 HARDSHELL RESEVOIR
K991973 · Terumo Medical Corp. · Sep 1999
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K990239 · Cobe Cardiovascular, Inc. · May 1999