Sunmed Haemostatic Valves
FDA 510(k) K153685 · Sunny Medical Device (Shenzhen) Co., Ltd.
510(k) numberK153685
Submission
- Device name
- Sunmed Haemostatic Valves
- Applicant
- Sunny Medical Device (Shenzhen) Co., Ltd.
Irvine, CA, US - Received
- December 22, 2015
- Decision date
- October 13, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
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| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
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More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K191827 | Sunmed Disposable Angio-Closure PadsDXC · Traditional | 03/16/2020SE |
| K160190 | Sunmed Control SyringesDXT · Traditional | 11/10/2016SE |
| K140356 | Summed High Pressure LineDQO · Traditional | 03/20/2015SE |
| K133795 | Summed Inflation Device KitMAV · Traditional | 12/12/2014SE |
| K120119 | Sunmed Guide WireDQX · Traditional | 05/11/2012SE |
Questions and answers
When was Sunmed Haemostatic Valves cleared by the FDA?
Sunmed Haemostatic Valves (K153685) received a 510(k) decision of Substantially Equivalent on October 13, 2016, 296 days after the submission was received.
What is the product code of K153685?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.