Combat Ready Clamp
FDA 510(k) K130482 · Combat Medical Systems, LLC
510(k) numberK130482
Submission
- Device name
- Combat Ready Clamp
- Applicant
- Combat Medical Systems, LLC
Westminster, CO, US - Received
- February 25, 2013
- Decision date
- April 29, 2013
- 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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| 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 |
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Questions and answers
When was Combat Ready Clamp cleared by the FDA?
Combat Ready Clamp (K130482) received a 510(k) decision of Substantially Equivalent on April 29, 2013, 63 days after the submission was received.
What is the product code of K130482?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.