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FDA 510(k)

THEROX INFUSION CATHETER, MODEL INCA-1

K-Number: K052637 · 2006-03-08

ApplicantTherox, Inc.
Decision Date2006-03-08
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THEROX INFUSION CATHETER, MODEL INCA-1 is the device name listed in this FDA 510(k) record. The listed applicant is Therox, Inc.. It received FDA 510(k) clearance on 2006-03-08 under 510(k) number K052637. 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 THEROX INFUSION CATHETER, MODEL INCA-1?

THEROX INFUSION CATHETER, MODEL INCA-1 is a medical device that received FDA 510(k) clearance on 2006-03-08. The listed applicant is Therox, Inc.. The 510(k) number is K052637.

When did THEROX INFUSION CATHETER, MODEL INCA-1 receive FDA 510(k) clearance?

THEROX INFUSION CATHETER, MODEL INCA-1 received FDA 510(k) clearance on 2006-03-08, under 510(k) number K052637.

Who is the listed applicant for THEROX INFUSION CATHETER, MODEL INCA-1?

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

What is the FDA product code for THEROX INFUSION CATHETER, MODEL INCA-1?

The FDA product code for THEROX INFUSION CATHETER, MODEL INCA-1 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 Therox, 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.

K971719THEROX INFUSION GUIDEWIRES

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

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