Vascular Solutions D-Stat Clamp Hemostatic Clamp
FDA 510(k) K040730 · Vascular Solutions, Inc.
510(k) numberK040730
Submission
- Device name
- Vascular Solutions D-Stat Clamp Hemostatic Clamp
- Applicant
- Vascular Solutions, Inc.
Minneapolis, MN, US - Received
- March 22, 2004
- Decision date
- June 18, 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 |
|---|---|---|
| K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon…LOX · Traditional | 05/31/2024SE |
| K230637 | Wattson temporary pacing guidewire (2250)DQX · Traditional | 05/05/2023SE |
| K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272)…DQY · Special | 08/18/2022SE |
| K221470 | Langston dual lumen catheterDQO · Special | 06/17/2022SE |
| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold…DQY · Traditional | 02/09/2022SE |
| K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireDQX · Traditional | 02/09/2022SE |
| K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterDQY · Traditional | 04/30/2021SE |
| K193119 | Twin-Pass Dual Access CatheterDQY · Traditional | 06/29/2020SE |
| K200720 | D-Stat Radial Topical HemostatQSX · Special | 06/26/2020SE |
| K192454 | Wattson Temporary Pacing GuidewireDQX · Traditional | 01/15/2020SE |
Questions and answers
When was Vascular Solutions D-Stat Clamp Hemostatic Clamp cleared by the FDA?
Vascular Solutions D-Stat Clamp Hemostatic Clamp (K040730) received a 510(k) decision of Substantially Equivalent on June 18, 2004, 88 days after the submission was received.
What is the product code of K040730?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.