The following data is part of a premarket notification filed by Jostra Ag with the FDA for Venous Hardshell Cardiotomy Resevoir, Model Vhk 4201.
| Device ID | K003551 |
| 510k Number | K003551 |
| Device Name: | VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | JOSTRA AG 17511 ARMSTRONG AVE. Irvine, CA 92614 -5686 |
| Contact | Kathleen Johnson |
| Correspondent | Kathleen Johnson JOSTRA AG 17511 ARMSTRONG AVE. Irvine, CA 92614 -5686 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-17 |
| Decision Date | 2001-07-11 |