The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Cardio-cool.
Device ID | K860523 |
510k Number | K860523 |
Device Name: | CARDIO-COOL |
Classification | Heat-exchanger, Cardiopulmonary Bypass |
Applicant | BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
Contact | Ann M Riley |
Correspondent | Ann M Riley BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
Product Code | DTR |
CFR Regulation Number | 870.4240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-12 |
Decision Date | 1986-04-29 |