The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Ventricular Catheter.
Device ID | K200950 |
510k Number | K200950 |
Device Name: | Ventricular Catheter |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-04-09 |
Decision Date | 2020-05-08 |