Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CD LEYCOM PRESSURE/VOLUME CATHETERS

K-Number: K031599 · 2003-12-09

ApplicantCd Leycom BV
Decision Date2003-12-09
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CD LEYCOM PRESSURE/VOLUME CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Cd Leycom BV. It received FDA 510(k) clearance on 2003-12-09 under 510(k) number K031599. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CD LEYCOM PRESSURE/VOLUME CATHETERS?

CD LEYCOM PRESSURE/VOLUME CATHETERS is a medical device that received FDA 510(k) clearance on 2003-12-09. The listed applicant is Cd Leycom BV. The 510(k) number is K031599.

When did CD LEYCOM PRESSURE/VOLUME CATHETERS receive FDA 510(k) clearance?

CD LEYCOM PRESSURE/VOLUME CATHETERS received FDA 510(k) clearance on 2003-12-09, under 510(k) number K031599.

Who is the listed applicant for CD LEYCOM PRESSURE/VOLUME CATHETERS?

The FDA 510(k) record lists Cd Leycom BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CD LEYCOM PRESSURE/VOLUME CATHETERS?

The FDA product code for CD LEYCOM PRESSURE/VOLUME CATHETERS is DQO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cd Leycom BV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K030524CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMENK003020CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER

Related Devices (Code: DQO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑