The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Miethke Shunt System Gav 2.0 And Sa 2.0 Valves.
| Device ID | K190174 |
| 510k Number | K190174 |
| Device Name: | Miethke Shunt System GAV 2.0 And SA 2.0 Valves |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Kathy A. Racosky |
| Correspondent | Kathy A. Racosky Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-01 |
| Decision Date | 2019-07-05 |