K831801 is an FDA 510(k) clearance for the HEMOCLAV VENOUS CATHETER. This device is classified as a Cannula, A-v Shunt (Class II - Special Controls, product code FIQ).
Submitted by Exo, Inc. (Walker, US). The FDA issued a Cleared decision on July 7, 1983, 34 days after receiving the submission on June 3, 1983.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K831801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1983 |
| Decision Date | July 07, 1983 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | FIQ - Cannula, A-v Shunt |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |