FDA 510(k)

ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION

K-Number: K912477 · 1991-11-05

ApplicantInterventional Therapeutics Corp.

Decision Date1991-11-05

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Therapeutics Corp.. It received FDA 510(k) clearance on 1991-11-05 under 510(k) number K912477. 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 ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION?

ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-11-05. The listed applicant is Interventional Therapeutics Corp.. The 510(k) number is K912477.

When did ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION receive FDA 510(k) clearance?

ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION received FDA 510(k) clearance on 1991-11-05, under 510(k) number K912477.

Who is the listed applicant for ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION?

The FDA 510(k) record lists Interventional Therapeutics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION?

The FDA product code for ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Interventional Therapeutics Corp. as applicant

K960832OCCLUSION BALLOON CATHETER K950398CATHETER, BALLOON TYPE K945588DISPOSABLE 1CC SYRINGE WITH LUER LOCK K944354CONTOUR EMBOLI K930456INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR K914866ITC CONTOUR EMBOLI, MODIFICATION

View all 28 devices →

Related Devices (Code: DQO)

K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular K252702Bioptimal 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 Vascular K250751DualView CatheterTerumo Corporation K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC K242420pNOVUS 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.