Cleared Special

K033714 - MVR 1200 PC: SORIN MONOLYTH VENOUS RESE...

K033714 is an FDA 510(k) clearance for MVR 1200 PC: SORIN MONOLYTH VENOUS RESE..., manufactured by Dideco S.P.A.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Special 510(k) pathway after a 15-day FDA review.

K033714 · Dideco S.P.A. · Cardiovascular device
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Dec 2003
Decision
15d
Days
Class 2
Risk

K033714 is an FDA 510(k) clearance for the MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE C.... Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Dideco S.P.A. (Waltham, US). The FDA issued a Cleared decision on December 11, 2003 after a review of 15 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 Dideco S.P.A. devices

FDA 510(k) Submission Details - K033714

510(k) Number K033714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2003
Decision Date December 11, 2003
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
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 138
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K033714.
CAPIOX FLEXIBLE VENOUS RESERVOIR
K040023 · Terumo Cardiovascular Systems Corp. · Mar 2004
CAPIOX CARDIOTOMY RESERVOIR
K033800 · Terumo Cardiovascular Systems Corporation · Feb 2004
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
K033641 · Cobe Cardiovascular, Inc. · Dec 2003
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
K031700 · Medtronic Perfusion Systems · Aug 2003
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
K030726 · Gish Biomedical, Inc. · May 2003
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
K024065 · Gish Biomedical, Inc. · Mar 2003