Cleared Special

MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 (K030141) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K030141 · Cardiovention, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 51
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