The following data is part of a premarket notification filed by Sparta Instrument Corp. with the FDA for Ghajar Intraventricular Catheter Guide.
| Device ID | K854475 |
| 510k Number | K854475 |
| Device Name: | GHAJAR INTRAVENTRICULAR CATHETER GUIDE |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | SPARTA INSTRUMENT CORP. 333 WEST WASKER DRIVE #1900 Chicago, IL 60606 |
| Contact | Joseph R Radzius |
| Correspondent | Joseph R Radzius SPARTA INSTRUMENT CORP. 333 WEST WASKER DRIVE #1900 Chicago, IL 60606 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-07 |
| Decision Date | 1986-02-20 |