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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Allengers Medical Systems Limited. It received FDA 510(k) clearance on 2022-05-03 under 510(k) 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. The listed applicant is Allengers Medical Systems Limited. The 510(k) number is K220311.

When did Cardiovascular Angiography System receive FDA 510(k) clearance?

Cardiovascular Angiography System received FDA 510(k) clearance on 2022-05-03, under 510(k) number K220311.

Who is the listed applicant for Cardiovascular Angiography System?

The FDA 510(k) record lists Allengers Medical Systems Limited as the applicant. This does not by itself establish the device manufacturer.

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.

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