Aircast Venaflow System (Modification)
FDA 510(k) K961676 · Aircast, Inc.
510(k) numberK961676
Submission
- Device name
- Aircast Venaflow System (Modification)
- Applicant
- Aircast, Inc.
Summit, NJ, US - Received
- April 12, 1996
- Decision date
- March 28, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JOW – Sleeve, Limb, Compressible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5800
- Specialty
- Cardiovascular
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|---|---|---|---|
| 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 |
|---|---|---|
| K024019 | Arterialflow System, Model 32AJOW · Traditional | 06/03/2003SE |
| K023800 | Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017JOW · Traditional | 02/10/2003SE |
| K992454 | Venaflow System, Model 30AJOW · Traditional | 01/13/2000SE |
| K964238 | Aircast Vena Flow Sterile Disposable CuffsJOW · Traditional | 09/08/1997SE |
| K933977 | Aircast Edemaflow SystemJOW · Traditional | 12/07/1993SE |
| K932900 | Aircast Venaflow SystemJOW · Traditional | 10/25/1993SE |
| K925677 | Autochill Accessory KitILO · Traditional | 04/14/1993SE |
| K812094 | Aircast Pneumatic Knee BraceITQ · Traditional | 08/13/1981SE |
| K810288 | Aircast Tennis Arm BandIQI · Traditional | 02/12/1981SE |
| K780979 | Airstirrup Pneumatic Ankle BraceIQI · Traditional | 06/30/1978SE |
Questions and answers
When was Aircast Venaflow System (Modification) cleared by the FDA?
Aircast Venaflow System (Modification) (K961676) received a 510(k) decision of Substantially Equivalent on March 28, 1997, 350 days after the submission was received.
What is the product code of K961676?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.