Fogarty Occluder Pad
FDA 510(k) K831809 · Thomas J. Fogarty, M.D.
510(k) numberK831809
Submission
- Device name
- Fogarty Occluder Pad
- Applicant
- Thomas J. Fogarty, M.D.
Walker, MI, US - Received
- June 6, 1983
- Decision date
- August 27, 1984
- 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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| 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 |
|---|---|---|
| K902453 | Oscillometric Pulse Detection DeviceDRS · Traditional | 08/23/1990SE |
| K884154 | Transluminal Endarterectomy DeviceLIF · Traditional | 12/27/1988SE |
| K841310 | Gastrointestinal DilatorKNQ · Traditional | 07/31/1984SE |
| K834451 | Coaxial Balloon Gastroesophageal DilaKNQ · Traditional | 02/04/1984SE |
| K831384 | Coaxial Balloon Urethral DilatorFAH · Traditional | 07/26/1983SE |
Questions and answers
When was Fogarty Occluder Pad cleared by the FDA?
Fogarty Occluder Pad (K831809) received a 510(k) decision of Substantially Equivalent on August 27, 1984, 448 days after the submission was received.
What is the product code of K831809?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.