Cstat, Models 09-0014-01 and 09-0014-02
FDA 510(k) K032125 · Vascular Control Systems, Inc.
510(k) numberK032125
Submission
- Device name
- Cstat, Models 09-0014-01 and 09-0014-02
- Applicant
- Vascular Control Systems, Inc.
San Juan Capistrano, CA, US - Received
- July 10, 2003
- Decision date
- February 9, 2004
- 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
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 |
|---|---|---|
| K060573 | Burbank TenaculumHDC · Traditional | 04/21/2006SE |
| K052209 | VCS Doppler Transceiver, Model 09-0023-01DPW · Traditional | 09/06/2005SE |
| K031812 | Transvaginal Doppler Clamp, Models: 09-0016-01, 09-0016-02, 09-0016-03DXC · Traditional | 12/12/2003SE |
| K031358 | Transvaginal Doppler ProbeITX · Traditional | 05/09/2003SE |
| K030078 | Burbank Tenaculum, Model 09-0011-01HDC · Traditional | 01/24/2003SE |
| K023154 | Vcs-A Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02DXC · Traditional | 12/20/2002SE |
| K023024 | Transvaginal Doppler Probe, Model 09-0006-02ITX · Traditional | 09/26/2002SE |
| K011863 | Vcs-A Series ClampDXC · Traditional | 02/15/2002SE |
Questions and answers
When was Cstat, Models 09-0014-01 and 09-0014-02 cleared by the FDA?
Cstat, Models 09-0014-01 and 09-0014-02 (K032125) received a 510(k) decision of Substantially Equivalent on February 9, 2004, 214 days after the submission was received.
What is the product code of K032125?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.