The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Omnishunt System For Ventricular Shunting.
| Device ID | K903844 |
| 510k Number | K903844 |
| Device Name: | OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Contact | Marvin L Sussman |
| Correspondent | Marvin L Sussman CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-21 |
| Decision Date | 1990-12-28 |