Summed High Pressure Line
FDA 510(k) K140356 · Sunny Medical Device (Shenzhen) Co., Ltd.
510(k) numberK140356
Submission
- Device name
- Summed High Pressure Line
- Applicant
- Sunny Medical Device (Shenzhen) Co., Ltd.
Irvine, CA, US - Received
- February 12, 2014
- Decision date
- March 20, 2015
- 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
Other 510(k)s with product code DQO
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|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/TrayDQO · Traditional | Spectrum Vascular | 06/26/2026SE |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF…DQO · Traditional | Bioptimal International Pte. , Ltd. | 05/28/2026SE |
| K254278 | Arterial Pressure Monitoring Set/TrayDQO · Special | Spectrum Vascular | 03/25/2026SE |
| K250751 | DualView CatheterDQO · Traditional | Terumo Corporation | 07/17/2025SE |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 01/31/2025SE |
| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
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| K191827 | Sunmed Disposable Angio-Closure PadsDXC · Traditional | 03/16/2020SE |
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| K153685 | Sunmed Haemostatic ValvesDQX · Traditional | 10/13/2016SE |
| K133795 | Summed Inflation Device KitMAV · Traditional | 12/12/2014SE |
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Questions and answers
When was Summed High Pressure Line cleared by the FDA?
Summed High Pressure Line (K140356) received a 510(k) decision of Substantially Equivalent on March 20, 2015, 401 days after the submission was received.
What is the product code of K140356?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.