Venodyne V810
FDA 510(k) K110358 · Microtek Medical, Inc.
510(k) numberK110358
Submission
- Device name
- Venodyne V810
- Applicant
- Microtek Medical, Inc.
Columbus, MS, US - Received
- February 7, 2011
- Decision date
- May 5, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOW – Sleeve, Limb, Compressible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5800
- Specialty
- Cardiovascular
Other 510(k)s with product code JOW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL)JOW · Traditional | Bio Compression Systems, Inc. | 09/11/2026SE |
| K254217 | AerloomJOW · Traditional | Evolym, LLC | 08/31/2026SE |
| K253555 | Flexitouch® Plus Advanced Pneumatic Compression SystemJOW · Traditional | Tactile Medical | 07/31/2026SE |
| K253386 | DVT GarmentJOW · Traditional | Vistar Medical Supplies Co., Ltd. | 06/25/2026SE |
| K250242 | Compression Therapy Device (LGT-2202DVT)JOW · Traditional | Guangzhou Longest Medical Technology Co., Ltd. | 04/24/2026SE |
| K254267 | NanoPress 760A-BT (760A-BT)JOW · Traditional | Mego Afek , Ltd. | 02/24/2026SE |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX)JOW · Traditional | Bio Compression Systems, Inc. | 12/12/2025SE |
| K250190 | Sequential Compression System (SCD600)JOW · Traditional | Shenzhen Comen Medical Instruments Co.,Ltd | 12/08/2025SE |
| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special | Wellell, Inc. | 10/28/2025SE |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001)JOW · Special | Manamed, LLC | 09/17/2025SE |
More from Manamed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II…LHI · Traditional | 09/16/2025SE |
| K102971 | Freedomaire III Surgical Helmet System Model 10322STKFYA · Traditional | 02/23/2011SE |
| K062899 | Microtek Medical Surgical Gown/TogaFYA · Traditional | 01/25/2007SE |
| K060200 | Microtek Medical Warming DrapeKKX · Traditional | 05/31/2006SE |
| K050322 | Microtek Equipment DrapesKKX · Traditional | 05/17/2005SE |
| K022903 | ChillbusterDWJ · Traditional | 11/27/2002SE |
| K020956 | Vivosonic Dianostic Ultrasound Imaging Coupling MediaMUI · Traditional | 05/16/2002SE |
| K011318 | Venodyne DVT Advantage PlusJOW · Traditional | 10/25/2001SE |
| K001802 | Venodyne DVT Advantage Model 610JOW · Traditional | 01/09/2001SE |
| K950906 | Lesinski Surgical Ear DressingEFQ · Traditional | 06/22/1995SE |
Questions and answers
When was Venodyne V810 cleared by the FDA?
Venodyne V810 (K110358) received a 510(k) decision of Substantially Equivalent on May 5, 2011, 87 days after the submission was received.
What is the product code of K110358?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.