The following data is part of a premarket notification filed by Medtronic Bio-medicus, Inc. with the FDA for Bpx80 Bio-pump (bpx80).
Device ID | K973011 |
510k Number | K973011 |
Device Name: | BPX80 BIO-PUMP (BPX80) |
Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
Applicant | MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
Contact | Thomas K Johnsen |
Correspondent | Thomas K Johnsen MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
Product Code | KFM |
CFR Regulation Number | 870.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-13 |
Decision Date | 1998-02-25 |
Summary: | summary |