Comfortpress Vascular Compression Assist Device
FDA 510(k) K072167 · Advanced Vascular Dynamics
510(k) numberK072167
Submission
- Device name
- Comfortpress Vascular Compression Assist Device
- Applicant
- Advanced Vascular Dynamics
Portland, OR, US - Received
- August 6, 2007
- Decision date
- September 6, 2007
- 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
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| 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 |
|---|---|---|
| K151363 | Zephyr Vascular Compression DeviceDXC · Traditional | 07/31/2015SE |
| K142122 | Radar Vascular Compression DeviceDXC · Abbreviated | 12/04/2014SE |
| K131571 | Avd Right Radial DrapeKKX · Traditional | 01/31/2014SE |
| K093192 | Flochec Photo Plethysmographic DeviceJOM · Traditional | 02/12/2010SE |
| K092503 | Radar Vascular Compression DevicesDXC · Traditional | 11/19/2009SE |
| K090286 | Pressuremate Manual Femoral Access Compression DeviceDXC · Traditional | 03/23/2009SE |
| K040615 | Compressar Supercomfort Disc and Strongarm Supercomfort SystemDXC · Special | 06/01/2004SE |
Questions and answers
When was Comfortpress Vascular Compression Assist Device cleared by the FDA?
Comfortpress Vascular Compression Assist Device (K072167) received a 510(k) decision of Substantially Equivalent on September 6, 2007, 31 days after the submission was received.
What is the product code of K072167?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.