Cleared Special

K003724 - CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYS...

K003724 is the FDA 510(k) clearance for CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYS... by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DTR) cleared through the Special 510(k) pathway after a 17-day FDA review.

K003724 · Medtronic Vascular · Cardiovascular device
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Dec 2000
Decision
17d
Days
Class 2
Risk

K003724 is an FDA 510(k) clearance for the CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MO.... Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 21, 2000 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4240 - 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 Medtronic Vascular devices

Submission Details

510(k) Number K003724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2000
Decision Date December 21, 2000
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DTR Heat-exchanger, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4240
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 - DTR Heat-exchanger, Cardiopulmonary Bypass

All 76
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K003724.
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
K021830 · Cobe Cardiovascular, Inc. · Jul 2002
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER
K020106 · Gish Biomedical, Inc. · Apr 2002
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
K012898 · Cobe Cardiovascular, Inc. · Sep 2001
CAPIOX CARDIOPLEGIA
K982467 · Terumo Medical Corp. · Jun 1999
CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)
K973475 · Medtronic Vascular · Nov 1997
MYOCARDIAL PROTECTION SYSTEM
K953838 · Quest Medical, Inc. · Mar 1996