B-Capta
K-Number: K202154 · 2021-04-01
ApplicantLivanova Deutschland, GmbH
Decision Date2021-04-01
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
B-Capta is a medical device manufactured by Livanova Deutschland, GmbH. It received FDA 510(k) clearance on 2021-04-01 under approval number K202154. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the B-Capta?
B-Capta is a medical device that received FDA 510(k) clearance on 2021-04-01. It is manufactured by Livanova Deutschland, GmbH. The 510(k) number is K202154.
When was B-Capta approved by the FDA?
B-Capta received FDA 510(k) clearance on 2021-04-01, under approval number K202154.
What company makes B-Capta?
B-Capta is manufactured by Livanova Deutschland, GmbH.
What is the FDA product code for B-Capta?
The FDA product code for B-Capta is DRY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.