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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Livanova Deutschland, GmbH. It received FDA 510(k) clearance on 2021-04-01 under 510(k) 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. The listed applicant is Livanova Deutschland, GmbH. The 510(k) number is K202154.

When did B-Capta receive FDA 510(k) clearance?

B-Capta received FDA 510(k) clearance on 2021-04-01, under 510(k) number K202154.

Who is the listed applicant for B-Capta?

The FDA 510(k) record lists Livanova Deutschland, GmbH as the applicant. This does not by itself establish the device manufacturer.

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.

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