K834477 is an FDA 510(k) clearance for the DISPOS. SCOTT CANNULAS 16-1054 ETC.. This device is classified as a Catheter, Ventricular (Class II - Special Controls, product code HCA).
Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1984, 90 days after receiving the submission on December 20, 1983.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4100.
| 510(k) Number | K834477 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1983 |
| Decision Date | March 19, 1984 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | HCA - Catheter, Ventricular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4100 |