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)

ORIGEN DUAL LUMEN CATHETER

K-Number: K003288 · 2001-06-08

ApplicantOrigen Biomedical, Inc.
Decision Date2001-06-08
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ORIGEN DUAL LUMEN CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Origen Biomedical, Inc.. It received FDA 510(k) clearance on 2001-06-08 under 510(k) number K003288. 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 ORIGEN DUAL LUMEN CATHETER?

ORIGEN DUAL LUMEN CATHETER is a medical device that received FDA 510(k) clearance on 2001-06-08. The listed applicant is Origen Biomedical, Inc.. The 510(k) number is K003288.

When did ORIGEN DUAL LUMEN CATHETER receive FDA 510(k) clearance?

ORIGEN DUAL LUMEN CATHETER received FDA 510(k) clearance on 2001-06-08, under 510(k) number K003288.

Who is the listed applicant for ORIGEN DUAL LUMEN CATHETER?

The FDA 510(k) record lists Origen Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORIGEN DUAL LUMEN CATHETER?

The FDA product code for ORIGEN DUAL LUMEN CATHETER 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 Origen Biomedical, Inc. 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.

K113869ORIGEN REINFORCED DUAL LUMEN CATHETERK021702CRYOBAG, MODEL CBK003145ORIGEN BLADDER HOLDER

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.

↑