Cleared Traditional

K021694 - CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100

K021694 is an FDA 510(k) clearance for CARDIOVENTION POWERBASE CONSOLE, manufactured by Cardiovention, Inc.. The device is a Class 2 Cardiovascular device with product code DTQ cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K021694 · Cardiovention, Inc. · Cardiovascular device
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Jan 2003
Decision
231d
Days
Class 2
Risk

K021694 is an FDA 510(k) clearance for the CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-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 January 8, 2003 after a review of 231 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiovention, Inc. devices

FDA 510(k) Submission Details - K021694

510(k) Number K021694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2002
Decision Date January 08, 2003
Days to Decision 231 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 125d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTQ Device Classification - Class 2, Special Controls

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 42
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