The following data is part of a premarket notification filed by Electro-catheter Corp. with the FDA for Elecath Pulsatile Perfusion Pump.
| Device ID | K854975 |
| 510k Number | K854975 |
| Device Name: | ELECATH PULSATILE PERFUSION PUMP |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | ELECTRO-CATHETER CORP. 2100 FELVER COURT P.O. BOX 1214C Rahway, NJ 07065 |
| Contact | Silpe |
| Correspondent | Silpe ELECTRO-CATHETER CORP. 2100 FELVER COURT P.O. BOX 1214C Rahway, NJ 07065 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-12 |
| Decision Date | 1986-01-15 |