Favc: Femoral Artery Vascular Clamp - Model Number RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15
FDA 510(k) K964662 · Rmds, Inc.
510(k) numberK964662
Submission
- Device name
- Favc: Femoral Artery Vascular Clamp - Model Number RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15
- Applicant
- Rmds, Inc.
Vancouver, WA, US - Received
- November 21, 1996
- Decision date
- February 3, 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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| 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 |
| K970027 | Favc-M: Femoral Artery Vascular Clamp-Mobile (Model M100-M200) Favc-M Femoral Artery…DXC · Traditional | 08/08/1997SE |
Questions and answers
When was Favc: Femoral Artery Vascular Clamp - Model Number RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15 cleared by the FDA?
Favc: Femoral Artery Vascular Clamp - Model Number RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15 (K964662) received a 510(k) decision of Substantially Equivalent on February 3, 1997, 74 days after the submission was received.
What is the product code of K964662?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.