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FDA 510(k)

IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER

K-Number: K070011 · 2007-03-20

ApplicantIrvine Biomedical,Inc.(Ibi)
Decision Date2007-03-20
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Biomedical,Inc.(Ibi). It received FDA 510(k) clearance on 2007-03-20 under 510(k) number K070011. 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 IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER?

IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER is a medical device that received FDA 510(k) clearance on 2007-03-20. The listed applicant is Irvine Biomedical,Inc.(Ibi). The 510(k) number is K070011.

When did IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER receive FDA 510(k) clearance?

IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER received FDA 510(k) clearance on 2007-03-20, under 510(k) number K070011.

Who is the listed applicant for IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER?

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

What is the FDA product code for IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER?

The FDA product code for IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER is DQO.

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

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