Vasc Band hemostat
FDA 510(k) K142359 · Lepu Medical Technology (Beijing) Co., Ltd.
510(k) numberK142359
Submission
- Device name
- Vasc Band hemostat
- Applicant
- Lepu Medical Technology (Beijing) Co., Ltd.
Beijing, CN - Received
- August 25, 2014
- Decision date
- October 23, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional | Edwards Lifesciences | 06/05/2026SE |
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| K254060 | Life Saving TourniquetDXC · Traditional | TW Medical | 04/03/2026SE |
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| 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 |
|---|---|---|
| K172331 | Type I, Type II, Type III, Type IVDYB · Traditional | 03/02/2018SESK |
| K172099 | Shoocin Introducer KitDYB · Traditional | 10/05/2017SE |
| K141707 | Ultraskin Hydrophilic Guide WireDQX · Traditional | 01/21/2015SE |
| K123475 | Shoocin Introducer KitDYB · Traditional | 02/03/2014SE |
| K123473 | Hoper Ptca Balloon CatheterLOX · Traditional | 08/13/2013SE |
| K111837 | Radial Artery Compression TourniquetDXC · Traditional | 09/27/2011SE |
Questions and answers
When was Vasc Band hemostat cleared by the FDA?
Vasc Band hemostat (K142359) received a 510(k) decision of Substantially Equivalent on October 23, 2014, 59 days after the submission was received.
What is the product code of K142359?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.