Cleared Special

K033641 - SMARXT VVR4000I PLUS FILTERED HARDSHELL...

K033641 is an FDA 510(k) clearance for SMARXT VVR4000I PLUS FILTERED HARDSHELL..., manufactured by Cobe Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Special 510(k) pathway after a 21-day FDA review.

K033641 · Cobe Cardiovascular, Inc. · Cardiovascular device
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Dec 2003
Decision
21d
Days
Class 2
Risk

K033641 is an FDA 510(k) clearance for the SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800. 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 December 11, 2003 after a review of 21 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. 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.

View all Cobe Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K033641

510(k) Number K033641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2003
Decision Date December 11, 2003
Days to Decision 21 days
Submission Type Special
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
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 K033641.
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K024065 · Gish Biomedical, Inc. · Mar 2003