Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
K-Number: K221339 · 2022-06-09
ApplicantContego Medical, Inc.
Decision Date2022-06-09
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection is a medical device manufactured by Contego Medical, Inc.. It received FDA 510(k) clearance on 2022-06-09 under approval number K221339. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection?
Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection is a medical device that received FDA 510(k) clearance on 2022-06-09. It is manufactured by Contego Medical, Inc.. The 510(k) number is K221339.
When was Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection approved by the FDA?
Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection received FDA 510(k) clearance on 2022-06-09, under approval number K221339.
What company makes Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection?
Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection is manufactured by Contego Medical, Inc..
What is the FDA product code for Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection?
The FDA product code for Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection is LIT.
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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.