The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Biocor 200 Hardshell Venous Reservior.
| Device ID | K953821 |
| 510k Number | K953821 |
| Device Name: | BIOCOR 200 HARDSHELL VENOUS RESERVIOR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
| Contact | Leroy J Fischbach |
| Correspondent | Leroy J Fischbach MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-15 |
| Decision Date | 1996-03-07 |
| Summary: | summary |