Cleared Special

K030141 - MODIFICATION TO CARDIOVENTION POWERBASE...

K030141 is the FDA 510(k) clearance for MODIFICATION TO CARDIOVENTION POWERBASE... by Cardiovention, Inc.. It is a Class 2 Cardiovascular device (product code DTQ) cleared through the Special 510(k) pathway after a 42-day FDA review.

K030141 · Cardiovention, Inc. · Cardiovascular device
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Feb 2003
Decision
42d
Days
Class 2
Risk

K030141 is an FDA 510(k) clearance for the MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by Cardiovention, Inc. (Santa Clara, US). The FDA issued a Cleared decision on February 26, 2003 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - 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 Cardiovention, Inc. devices

Submission Details

510(k) Number K030141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2003
Decision Date February 26, 2003
Days to Decision 42 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4220
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 - DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass

All 23
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K030141.
ADVANCED PERFUSION SYSTEM 1
K131041 · Terumo Cardiovascular Systems Corp. · Feb 2014
CARDIOHELP SYSTEM
K102726 · Maquet Cardiopulmonary, AG · Apr 2011
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
K022947 · Terumo Cardiovascular Systems Corp. · Mar 2003
SARNS 8000 MODULAR PERFUSION SYSTEM
K915183 · 3M Health Care, Sarns · Jul 1992
SARNS 9000 HEART-LUNG CONSOLE
K871131 · 3M Health Care, Sarns · May 1987
ONGUARD 1000, CATALOG #043611-000 & 043611-001
K870976 · Cobe Laboratories, Inc. · May 1987