The following data is part of a premarket notification filed by Vitaid, Ltd. with the FDA for Agishi Ascites Pump Peritoneocaval Shunt Pump.
| Device ID | K894794 |
| 510k Number | K894794 |
| Device Name: | AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP |
| Classification | Shunt, Peritoneal |
| Applicant | VITAID, LTD. 147 OLD ORCHARD GROVE TORONTO, ONTARIO, CANADA M5m 2e1, CA |
| Contact | G Stewart |
| Correspondent | G Stewart VITAID, LTD. 147 OLD ORCHARD GROVE TORONTO, ONTARIO, CANADA M5m 2e1, CA |
| Product Code | KPM |
| CFR Regulation Number | 876.5955 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-28 |
| Decision Date | 1989-11-21 |