K020728 is an FDA 510(k) clearance for the MIETHKE SHUNT SYSTEM. This device is classified as a Catheter, Ventricular (Class II - Special Controls, product code HCA).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on April 5, 2002, 30 days after receiving the submission on March 6, 2002.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4100.
| 510(k) Number | K020728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2002 |
| Decision Date | April 05, 2002 |
| Days to Decision | 30 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 |