The following data is part of a premarket notification filed by Livanova Deutschland Gmbh with the FDA for B-capta.
Device ID | K202154 |
510k Number | K202154 |
Device Name: | B-Capta |
Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
Applicant | LivaNova Deutschland GmbH Lindberghstr. 25 Munich, DE 80939 |
Contact | Mattia Ronchetti |
Correspondent | Mattia Ronchetti LivaNova Deutschland GmbH Lindberghstr. 25 Munich, DE 80939 |
Product Code | DRY |
CFR Regulation Number | 870.4330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-03 |
Decision Date | 2021-04-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() B-CAPTA 79240105 5724415 Live/Registered |
SORIN GROUP ITALIA S.R.L. 2018-06-28 |