The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Heyer-schulte (csf) Ventri Access(reserv/antecham.
| Device ID | K891456 |
| 510k Number | K891456 |
| Device Name: | HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | BAXTER HEALTHCARE CORP. 7280 NORTH CALDWELL Niles, IL 60648 |
| Contact | Morizio, R.n. |
| Correspondent | Morizio, R.n. BAXTER HEALTHCARE CORP. 7280 NORTH CALDWELL Niles, IL 60648 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-15 |
| Decision Date | 1989-06-23 |