Cleared Special

CD LEYCOM PRESSURE/VOLUME CATHETERS (K031599) - FDA 510(k) Clearance

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

K031599 · Cd Leycom BV · Cardiovascular device
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Dec 2003
Decision
202d
Days
Class 2
Risk

K031599 is an FDA 510(k) clearance for the CD LEYCOM PRESSURE/VOLUME CATHETERS. 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 December 9, 2003 after a review of 202 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cd Leycom BV devices

Submission Details

510(k) Number K031599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2003
Decision Date December 09, 2003
Days to Decision 202 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 125d · This submission: 202d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 144
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