Cardiovascular Angiography System
K-Number: K220311 · 2022-05-03
ApplicantAllengers Medical Systems Limited
Decision Date2022-05-03
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Cardiovascular Angiography System is a medical device manufactured by Allengers Medical Systems Limited. It received FDA 510(k) clearance on 2022-05-03 under approval number K220311. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cardiovascular Angiography System?
Cardiovascular Angiography System is a medical device that received FDA 510(k) clearance on 2022-05-03. It is manufactured by Allengers Medical Systems Limited. The 510(k) number is K220311.
When was Cardiovascular Angiography System approved by the FDA?
Cardiovascular Angiography System received FDA 510(k) clearance on 2022-05-03, under approval number K220311.
What company makes Cardiovascular Angiography System?
Cardiovascular Angiography System is manufactured by Allengers Medical Systems Limited.
What is the FDA product code for Cardiovascular Angiography System?
The FDA product code for Cardiovascular Angiography System is OWB.
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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.