B-Capta

Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

LivaNova Deutschland GmbH

The following data is part of a premarket notification filed by Livanova Deutschland Gmbh with the FDA for B-capta.

Pre-market Notification Details

Device IDK202154
510k NumberK202154
Device Name:B-Capta
ClassificationMonitor, Blood-gas, On-line, Cardiopulmonary Bypass
Applicant LivaNova Deutschland GmbH Lindberghstr. 25 Munich,  DE 80939
ContactMattia Ronchetti
CorrespondentMattia Ronchetti
LivaNova Deutschland GmbH Lindberghstr. 25 Munich,  DE 80939
Product CodeDRY  
CFR Regulation Number870.4330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-03
Decision Date2021-04-01

Trademark Results [B-Capta]

Mark Image

Registration | Serial
Company
Trademark
Application Date
B-CAPTA
B-CAPTA
79240105 5724415 Live/Registered
SORIN GROUP ITALIA S.R.L.
2018-06-28

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