DualView Catheter
FDA 510(k) K250751 · Terumo Corporation
510(k) numberK250751
Submission
- Device name
- DualView Catheter
- Applicant
- Terumo Corporation
Tokyo, JP - Received
- March 12, 2025
- Decision date
- July 17, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
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| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
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| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 08/08/2023SE |
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| K170417 | Glidewire GTDQX · Traditional | 09/15/2017SE |
| K130493 | Capiox RX05 Hollow Fiber Oxygenator/ReservoirDTZ · Special | 03/13/2013SE |
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Questions and answers
When was DualView Catheter cleared by the FDA?
DualView Catheter (K250751) received a 510(k) decision of Substantially Equivalent on July 17, 2025, 127 days after the submission was received.
What is the product code of K250751?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.