The following data is part of a premarket notification filed by Schiff & Co. with the FDA for Jostra Venous Hardshell Cardiotomic Reservoir Vhk 4200.
| Device ID | K982136 |
| 510k Number | K982136 |
| Device Name: | JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Anne M Cesario |
| Correspondent | Anne M Cesario SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-17 |
| Decision Date | 1999-03-24 |