Modification to Femostop Femoral Compression System
FDA 510(k) K080206 · Radi Medical Systems AB
510(k) numberK080206
Submission
- Device name
- Modification to Femostop Femoral Compression System
- Applicant
- Radi Medical Systems AB
Uppsala, SE - Received
- January 28, 2008
- Decision date
- February 26, 2008
- 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 |
|---|---|---|
| K123984 | Quantien Measurement SystemDQK · Special | 03/28/2013SE |
| K092105 | Radianalyzer XpressDQK · Traditional | 10/09/2009SE |
| K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverDXO · Traditional | 07/01/2008SE |
| K062769 | Pressurewire Certus, Models 12006 and 12306DXO · Special | 12/04/2006SE |
| K042628 | Modification to: Radianalyzer, Model 12711DQK · Traditional | 01/19/2005SE |
| K033291 | Topseal Hemostatic Dressing, Model 11150QSY · Traditional | 03/17/2004SE |
| K031662 | Pressure Wire Sensor, Models 12004/12304DXO · Special | 06/06/2003SE |
| K024107 | Femostop Femoral Compression SystemDXC · Special | 12/24/2002SE |
| K022188 | Radianalyzer, Model 12710DQK · Traditional | 10/03/2002SE |
| K022187 | Pressure Wire Sensor, Models 12003/12303, 12004/12304DXO · Traditional | 09/24/2002SE |
Questions and answers
When was Modification to Femostop Femoral Compression System cleared by the FDA?
Modification to Femostop Femoral Compression System (K080206) received a 510(k) decision of Substantially Equivalent on February 26, 2008, 29 days after the submission was received.
What is the product code of K080206?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.