The following data is part of a premarket notification filed by Advocacy International, Ltd. with the FDA for Polystan Verticlude Blood Pump.
| Device ID | K813035 |
| 510k Number | K813035 |
| Device Name: | POLYSTAN VERTICLUDE BLOOD PUMP |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Applicant | ADVOCACY INTERNATIONAL, LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DWB |
| CFR Regulation Number | 870.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-28 |
| Decision Date | 1981-11-27 |