PreludeSYNC DISTAL Radial Compression System
FDA 510(k) K180723 · Merit Medical Systems, Inc.
510(k) numberK180723
Submission
- Device name
- PreludeSYNC DISTAL Radial Compression System
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- March 19, 2018
- Decision date
- April 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
Other 510(k)s with product code DXC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262086 | PreludeSYNC Radial Compression DeviceDXC · Special | Merit Medical Systems, Inc. | 07/22/2026SE |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional | Edwards Lifesciences | 06/05/2026SE |
| K252772 | Arc Adjustable Radial Cuff Compression DeviceDXC · Traditional | Tz Medical, Inc. | 05/22/2026SE |
| K254060 | Life Saving TourniquetDXC · Traditional | TW Medical | 04/03/2026SE |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp…DXC · Traditional | Arc Trauma, LLC | 12/31/2025SE |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional | Medline Industries, LP | 11/20/2025SE |
| K232577 | Radial Compression DeviceDXC · Traditional | Ningbo Dizegens Medical Science Co.,Ltd | 01/18/2024SE |
| K230281 | PicoclampDXC · Traditional | Kono Seisakusho Co., Ltd. | 10/23/2023SE |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional | Compression Works, Inc. | 03/03/2023SE |
| K230248 | ViolaDXC · Special | Vascular Graft Solutions, Ltd. | 02/28/2023SE |
More from Vascular Graft Solutions, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | 07/27/2026SE |
| K262086 | PreludeSYNC Radial Compression DeviceDXC · Special | 07/22/2026SE |
| K254073 | StatSeal DiscFRO · Traditional | 05/13/2026SE |
| K251802 | STAR RF Ablation SystemGXI · Traditional | 02/13/2026SE |
| K252892 | SCOUT MD Surgical Guidance SystemNEU · Traditional | 12/19/2025SE |
| K250853 | Merit SyringeFMF · Special | 11/04/2025SE |
| K251265 | Resilience Fully Covered Esophageal Stent SystemESW · Traditional | 07/23/2025SE |
| K250909 | Prelude Wave Hydrophilic Sheath IntroducerDYB · Special | 04/25/2025SE |
| K242873 | Ventrax Delivery SystemDQY · Special | 01/15/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | 01/15/2025SE |
Questions and answers
When was PreludeSYNC DISTAL Radial Compression System cleared by the FDA?
PreludeSYNC DISTAL Radial Compression System (K180723) received a 510(k) decision of Substantially Equivalent on April 17, 2018, 29 days after the submission was received.
What is the product code of K180723?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.