Favc-M: Femoral Artery Vascular Clamp-Mobile (Model M100-M200) Favc-M Femoral Artery Vascular Clamp-Mobile Adj Belt 6005
FDA 510(k) K970027 · Rmds, Inc.
510(k) numberK970027
Submission
- Device name
- Favc-M: Femoral Artery Vascular Clamp-Mobile (Model M100-M200) Favc-M Femoral Artery Vascular Clamp-Mobile Adj Belt 6005
- Applicant
- Rmds, Inc.
Vancouver, WA, US - Received
- January 3, 1997
- Decision date
- August 8, 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
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| K254060 | Life Saving TourniquetDXC · Traditional | TW Medical | 04/03/2026SE |
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| 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 |
| K973216 | Favc-Hh: Femoral Artery Vascular Clamp-Hand Held: 1/2 & 3 Pounds (RMDS810T/815T/820T)DXC · Traditional | 11/25/1997SE |
| 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-M: Femoral Artery Vascular Clamp-Mobile (Model M100-M200) Favc-M Femoral Artery Vascular Clamp-Mobile Adj Belt 6005 cleared by the FDA?
Favc-M: Femoral Artery Vascular Clamp-Mobile (Model M100-M200) Favc-M Femoral Artery Vascular Clamp-Mobile Adj Belt 6005 (K970027) received a 510(k) decision of Substantially Equivalent on August 8, 1997, 217 days after the submission was received.
What is the product code of K970027?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.