The following data is part of a premarket notification filed by Neurodynamics, Inc. with the FDA for Tri-flow Catheter.
| Device ID | K875205 |
| 510k Number | K875205 |
| Device Name: | TRI-FLOW CATHETER |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | NEURODYNAMICS, INC. P.O. BOX 603, LENOX HILL STATION New York, NY 10021 |
| Contact | Margaret Meade |
| Correspondent | Margaret Meade NEURODYNAMICS, INC. P.O. BOX 603, LENOX HILL STATION New York, NY 10021 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-18 |
| Decision Date | 1988-05-31 |