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 |