The following data is part of a premarket notification filed by Aircast, Inc. with the FDA for Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017.
| Device ID | K023800 |
| 510k Number | K023800 |
| Device Name: | VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | AIRCAST, INC. 92 RIVER RD. Summit, NJ 07902 |
| Contact | Stephen L Kenney |
| Correspondent | Stephen L Kenney AIRCAST, INC. 92 RIVER RD. Summit, NJ 07902 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-14 |
| Decision Date | 2003-02-10 |