CD Leycom Pressure/Volume Catheters

FDA 510(k) K031599 · Cd Leycom BV

Substantially Equivalent

510(k) numberK031599

Submission

Device name
CD Leycom Pressure/Volume Catheters
Applicant
Cd Leycom BV
Zoetermeer, NL
Received
May 21, 2003
Decision date
December 9, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DQO – Catheter, Intravascular, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1200
Specialty
Cardiovascular

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K261455Arterial Pressure Monitoring Set/TrayDQO · Traditional Spectrum Vascular06/26/2026SE
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K254278Arterial Pressure Monitoring Set/TrayDQO · Special Spectrum Vascular03/25/2026SE
K250751DualView CatheterDQO · Traditional Terumo Corporation07/17/2025SE
K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional Gentuity, LLC01/31/2025SE
K242420pNOVUS 21 MicrocatheterDQO · Traditional Phenox, Ltd.11/12/2024SE
K233268Impress Angiographic CatheterDQO · Special Merit Medical Systems, Inc.05/22/2024SE
K233975Zoom 6F Insert CathetersDQO · Traditional Imperative Care, Inc.04/02/2024SE
K232536Soldier MicrocatheterDQO · Traditional Embolx, Inc.02/23/2024SE
K232573INFINITI™ Ambi Angiographic CatheterDQO · Traditional Cordis US Corp11/21/2023SE

More from Cordis US Corp

510(k)DeviceDecision
K030524CD Leycom 7 FR Pressure/Volume Catheter (10 MM Electrode Spacing) Pressure/Volume…OBJ · Special 03/03/2003SE
K003020Cardiac Function Laboratory; Pressure Interface; Pressure / Volume CatheterDQO · Traditional 05/11/2001SE

Questions and answers

When was CD Leycom Pressure/Volume Catheters cleared by the FDA?

CD Leycom Pressure/Volume Catheters (K031599) received a 510(k) decision of Substantially Equivalent on December 9, 2003, 202 days after the submission was received.

What is the product code of K031599?

The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.