Cleared Traditional

K003020 - CARDIAC FUNCTION LABORATORY

Also marketed or referenced as:
PRESSURE INTERFACE PRESSURE / VOLUME CATHETER

K003020 is an FDA 510(k) clearance for CARDIAC FUNCTION LABORATORY, manufactured by Cd Leycom BV. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K003020 · Cd Leycom BV · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
226d
Days
Class 2
Risk

K003020 is an FDA 510(k) clearance for the CARDIAC FUNCTION LABORATORY. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cd Leycom BV (Zoetermeer, NL). The FDA issued a Cleared decision on May 11, 2001 after a review of 226 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Cd Leycom BV devices

FDA 510(k) Submission Details - K003020

510(k) Number K003020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2000
Decision Date May 11, 2001
Days to Decision 226 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
101d slower than avg
Panel avg: 125d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 392
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K003020.
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COOK PRESSURE MONITORING CATHETER
K002254 · Cook, Inc. · Mar 2001
ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER
K003901 · AngioDynamics, Inc. · Jan 2001