K964238 is an FDA 510(k) clearance for the AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS. This device is classified as a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW).
Submitted by Aircast, Inc. (Summit, US). The FDA issued a Cleared decision on September 8, 1997, 320 days after receiving the submission on October 23, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K964238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1996 |
| Decision Date | September 08, 1997 |
| Days to Decision | 320 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | JOW — Sleeve, Limb, Compressible |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5800 |