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FDA 510(k)

Stent Positioning Assistance System (SPAS)

K-Number: K221917 · 2022-08-19

ApplicantSeven Sons , Ltd.
Decision Date2022-08-19
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Stent Positioning Assistance System (SPAS) is a medical device manufactured by Seven Sons , Ltd.. It received FDA 510(k) clearance on 2022-08-19 under approval number K221917. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stent Positioning Assistance System (SPAS)?

Stent Positioning Assistance System (SPAS) is a medical device that received FDA 510(k) clearance on 2022-08-19. It is manufactured by Seven Sons , Ltd.. The 510(k) number is K221917.

When was Stent Positioning Assistance System (SPAS) approved by the FDA?

Stent Positioning Assistance System (SPAS) received FDA 510(k) clearance on 2022-08-19, under approval number K221917.

What company makes Stent Positioning Assistance System (SPAS)?

Stent Positioning Assistance System (SPAS) is manufactured by Seven Sons , Ltd..

What is the FDA product code for Stent Positioning Assistance System (SPAS)?

The FDA product code for Stent Positioning Assistance System (SPAS) is DQX.

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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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