Venus Bulk Flow ONE
K-Number: K220605 · 2022-04-21
ApplicantKulzer, LLC
Decision Date2022-04-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Venus Bulk Flow ONE is a medical device manufactured by Kulzer, LLC. It received FDA 510(k) clearance on 2022-04-21 under approval number K220605. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Venus Bulk Flow ONE?
Venus Bulk Flow ONE is a medical device that received FDA 510(k) clearance on 2022-04-21. It is manufactured by Kulzer, LLC. The 510(k) number is K220605.
When was Venus Bulk Flow ONE approved by the FDA?
Venus Bulk Flow ONE received FDA 510(k) clearance on 2022-04-21, under approval number K220605.
What company makes Venus Bulk Flow ONE?
Venus Bulk Flow ONE is manufactured by Kulzer, LLC.
What is the FDA product code for Venus Bulk Flow ONE?
The FDA product code for Venus Bulk Flow ONE is EBF.
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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.