The following data is part of a premarket notification filed by Aesculap Inc. with the FDA for Progav Programmable Shunt System, Progav 2.0 Adjustable Shunt System, Prosa Adjustable Shunt System.
| Device ID | K161853 |
| 510k Number | K161853 |
| Device Name: | ProGAV Programmable Shunt System, ProGAV 2.0 Adjustable Shunt System, ProSA Adjustable Shunt System |
| 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 | 2016-07-06 |
| Decision Date | 2017-02-27 |
| Summary: | summary |