Favc-Hh: Femoral Artery Vascular Clamp-Hand Held: 1/2 & 3 Pounds (RMDS810T/815T/820T)
FDA 510(k) K973216 · Rmds, Inc.
510(k) numberK973216
Submission
- Device name
- Favc-Hh: Femoral Artery Vascular Clamp-Hand Held: 1/2 & 3 Pounds (RMDS810T/815T/820T)
- Applicant
- Rmds, Inc.
Vancouver, WA, US - Received
- August 27, 1997
- Decision date
- November 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K964663 | Favp: Femoral Artery Vascular Pad - Model Number PAD2EK-01, PAD2EK-2X, PAD5EK-R…DXC · Traditional | 12/11/1997SE |
| K970027 | Favc-M: Femoral Artery Vascular Clamp-Mobile (Model M100-M200) Favc-M Femoral Artery…DXC · Traditional | 08/08/1997SE |
| K964662 | Favc: Femoral Artery Vascular Clamp - Model Number RMDS 1000-15, RMDS 1000-20, RMDS…DXC · Traditional | 02/03/1997SE |
Questions and answers
When was Favc-Hh: Femoral Artery Vascular Clamp-Hand Held: 1/2 & 3 Pounds (RMDS810T/815T/820T) cleared by the FDA?
Favc-Hh: Femoral Artery Vascular Clamp-Hand Held: 1/2 & 3 Pounds (RMDS810T/815T/820T) (K973216) received a 510(k) decision of Substantially Equivalent on November 25, 1997, 90 days after the submission was received.
What is the product code of K973216?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.