FDA 510(k)

Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection

K-번호: K221339 · 2022-06-09

결정일2022-06-09

제품 코드LIT

자문 위원회CV

결정Substantially Equivalent

기기 요약

Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection is the device name listed in this FDA 510(k) record. The listed applicant is Contego Medical, Inc.. It received FDA 510(k) clearance on 2022-06-09 under 510(k) number K221339. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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. The listed applicant is Contego Medical, Inc.. The 510(k) number is K221339.

When did Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection receive FDA 510(k) clearance?

Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection received FDA 510(k) clearance on 2022-06-09, under 510(k) number K221339.

Who is the listed applicant for Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection?

The FDA 510(k) record lists Contego Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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