The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Ventri-cath.
| Device ID | K931989 |
| 510k Number | K931989 |
| Device Name: | VENTRI-CATH |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | GESCO INTL., INC. P.O. BOX 690188 San Antonio, TX 78269 |
| Contact | Clyde N Baker |
| Correspondent | Clyde N Baker GESCO INTL., INC. P.O. BOX 690188 San Antonio, TX 78269 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-22 |
| Decision Date | 1993-07-21 |