Cleared Traditional

B-Capta

K202154 · Livanova Deutschland, GmbH · Cardiovascular
Apr 2021
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K202154 is an FDA 510(k) clearance for the B-Capta, a Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (Class II — Special Controls, product code DRY), submitted by Livanova Deutschland, GmbH (Munich, DE). The FDA issued a Cleared decision on April 1, 2021, 241 days after receiving the submission on August 3, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4330.

Submission Details

510(k) Number K202154 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2020
Decision Date April 01, 2021
Days to Decision 241 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRY — Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4330

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