K031123 is an FDA 510(k) clearance for the CODMAN BACTISEAL BARIUM STRIPED CATHETERS. This device is classified as a Catheter, Ventricular (Class II - Special Controls, product code HCA).
Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on May 14, 2003, 35 days after receiving the submission on April 9, 2003.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4100.
| 510(k) Number | K031123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2003 |
| Decision Date | May 14, 2003 |
| Days to Decision | 35 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCA - Catheter, Ventricular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4100 |