The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for V/p And L/p Catheter Passers.
| Device ID | K934391 |
| 510k Number | K934391 |
| Device Name: | V/P AND L/P CATHETER PASSERS |
| Classification | Instrument, Shunt System Implantation |
| Applicant | RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Product Code | GYK |
| CFR Regulation Number | 882.4545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-09 |
| Decision Date | 1993-11-19 |