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FDA 510(k)

DualView Catheter

K-Number: K250751 · 2025-07-17

ApplicantTerumo Corporation
Decision Date2025-07-17
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DualView Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corporation. It received FDA 510(k) clearance on 2025-07-17 under 510(k) number K250751. 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 DualView Catheter?

DualView Catheter is a medical device that received FDA 510(k) clearance on 2025-07-17. The listed applicant is Terumo Corporation. The 510(k) number is K250751.

When did DualView Catheter receive FDA 510(k) clearance?

DualView Catheter received FDA 510(k) clearance on 2025-07-17, under 510(k) number K250751.

Who is the listed applicant for DualView Catheter?

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

What is the FDA product code for DualView Catheter?

The FDA product code for DualView 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 VascularK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.K233268Impress Angiographic CatheterMerit Medical Systems, Inc.

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.

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