Cleared Special

K031599 - CD LEYCOM PRESSURE/VOLUME CATHETERS

K031599 is an FDA 510(k) clearance for CD LEYCOM PRESSURE/VOLUME CATHETERS, manufactured by Cd Leycom BV. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 202-day FDA review.

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.

FDA 510(k) Submission Details - K031599

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 125d · This submission: 202d
Pathway characteristics
Modification to existing cleared device.

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 489
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K031599.
ATLANTIS SR, MODEL C4020
K040776 · Boston Scientific Corp · Apr 2004
CREATION NM DIAGNOSTIC CATHETERS
K032888 · Neich Medical (Shenzhen) Company Limited · Feb 2004
PROGREAT
K033583 · Terumo Medical Corp. · Dec 2003
RINSPIRATION SYSTEM
K031485 · Kerberos Proximal Solutions · Sep 2003
MICRUS MICROCATHETER
K032624 · Micrus Corp. · Sep 2003
ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER
K032376 · AngioDynamics, Inc. · Aug 2003
K031599 · CD LEYCOM PRESSURE/VOLUME CATHETERS
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