K983331 is an FDA 510(k) clearance for the MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102. This device is classified as a Catheter, Ventricular (Class II - Special Controls, product code HCA).
Submitted by Medtronic PS Medical (Goleta, US). The FDA issued a Cleared decision on December 16, 1998, 85 days after receiving the submission on September 22, 1998.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4100.
| 510(k) Number | K983331 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 1998 |
| Decision Date | December 16, 1998 |
| Days to Decision | 85 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 |