The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Biocor Softshell Venous Reservoir (biocor Svr).
| Device ID | K972017 |
| 510k Number | K972017 |
| Device Name: | BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Contact | Lynn Lueders |
| Correspondent | Lynn Lueders MINNTECH CORP. 14605 28TH AVE. NORTH 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 | 1997-05-30 |
| Decision Date | 1997-09-10 |