Atraumax Surgical Clamp Model FOG-5048, 75MM Side
FDA 510(k) K901565 · Applied Vascular Devices, Inc.
510(k) numberK901565
Submission
- Device name
- Atraumax Surgical Clamp Model FOG-5048, 75MM Side
- Applicant
- Applied Vascular Devices, Inc.
Laguna Hills, CA, US - Received
- April 3, 1990
- Decision date
- June 12, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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| 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 |
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| 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 |
|---|---|---|
| K911730 | Surgical Obturator with SealGCJ · Traditional | 12/23/1991SE |
| K911589 | Disposable Surgical Trocar with SealGCJ · Traditional | 07/05/1991SE |
| K910339 | Avd Intimax Occlusion CatheterDQT · Traditional | 05/29/1991SE |
| K910372 | Intimax Thrombectomy CatheterDXE · Traditional | 04/26/1991SE |
| K911181 | Intimax(Tm) Irrigation CatheterGCA · Traditional | 04/18/1991SE |
| K910493 | Avd Intimax Cholangiography CatheterFGE · Traditional | 03/28/1991SE |
| K903848 | Diagnostic Intrascular CatheterDQO · Traditional | 03/25/1991SE |
| K905738 | Operative Cholangiographic CatheterFGE · Traditional | 03/21/1991SE |
| K910079 | Disposable Introducer SheathKDC · Traditional | 02/27/1991SE |
| K902256 | Irrigation Catheter 4, 6 and 10 FrenchDQY · Traditional | 02/15/1991SE |
Questions and answers
When was Atraumax Surgical Clamp Model FOG-5048, 75MM Side cleared by the FDA?
Atraumax Surgical Clamp Model FOG-5048, 75MM Side (K901565) received a 510(k) decision of Substantially Equivalent on June 12, 1990, 70 days after the submission was received.
What is the product code of K901565?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.