K003322 is an FDA 510(k) clearance for the CODMAN BACTISEAL 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 October 1, 2001, 342 days after receiving the submission on October 24, 2000.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4100.
| 510(k) Number | K003322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2000 |
| Decision Date | October 01, 2001 |
| Days to Decision | 342 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCA - Catheter, Ventricular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4100 |