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FDA 510(k)

Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter

K-Number: K230620 · 2023-08-08

ApplicantGentuity, LLC
Decision Date2023-08-08
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Gentuity, LLC. It received FDA 510(k) clearance on 2023-08-08 under 510(k) number K230620. 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 Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter?

Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is a medical device that received FDA 510(k) clearance on 2023-08-08. The listed applicant is Gentuity, LLC. The 510(k) number is K230620.

When did Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter receive FDA 510(k) clearance?

Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter received FDA 510(k) clearance on 2023-08-08, under 510(k) number K230620.

Who is the listed applicant for Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter?

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

What is the FDA product code for Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter?

The FDA product code for Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is DQO.

Other records listing Gentuity, LLC 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.

K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterK242239HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))K192922Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging 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

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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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