The following data is part of a premarket notification filed by Polystan C/o Vitalcor, Inc. with the FDA for Polystan Two Stage Catheters.
| Device ID | K874853 |
| 510k Number | K874853 |
| Device Name: | POLYSTAN TWO STAGE CATHETERS |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | POLYSTAN C/O VITALCOR, INC. 100 E. CHESTNUT AVE. Westmont, IL 60559 |
| Contact | Bill Huck |
| Correspondent | Bill Huck POLYSTAN C/O VITALCOR, INC. 100 E. CHESTNUT AVE. Westmont, IL 60559 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-25 |
| Decision Date | 1988-02-05 |