Omed Disposable Bulldog
FDA 510(k) K813499 · Omega-Med Intl., Inc.
510(k) numberK813499
Submission
- Device name
- Omed Disposable Bulldog
- Applicant
- Omega-Med Intl., Inc.
Mchenry, IL, US - Received
- December 14, 1981
- Decision date
- December 29, 1981
- 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
Other 510(k)s with product code DXC
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|---|---|---|---|
| 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 |
|---|---|---|
| K842603 | Omed Dispos. Instrument Guards · Traditional | 09/05/1984SE |
| K832441 | Suture-Aid BootiesKDC · Traditional | 03/05/1984SE |
| K830484 | Omed Ident-I-Band · Traditional | 03/24/1983SE |
| K822284 | Comply Neuromuscular StimulatorIPF · Traditional | 09/17/1982SE |
| K821334 | Omed Fabric Instrument Covers-Radiopaq · Traditional | 05/24/1982SE |
| K810883 | Omed Silicone Instrument CoversKDC · Traditional | 04/23/1981SE |
| K810269 | Omed Fabric Instrument CoversKDC · Traditional | 02/26/1981SE |
| K810260 | Omed Silicone LoopsKDC · Traditional | 02/26/1981SE |
Questions and answers
When was Omed Disposable Bulldog cleared by the FDA?
Omed Disposable Bulldog (K813499) received a 510(k) decision of Substantially Equivalent on December 29, 1981, 15 days after the submission was received.
What is the product code of K813499?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.