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FDA 510(k)

PerQseal Introducers

K-Number: K252309 · 2025-10-23

ApplicantVivasure Medical Limited
Decision Date2025-10-23
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PerQseal Introducers is a medical device manufactured by Vivasure Medical Limited. It received FDA 510(k) clearance on 2025-10-23 under approval number K252309. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PerQseal Introducers?

PerQseal Introducers is a medical device that received FDA 510(k) clearance on 2025-10-23. It is manufactured by Vivasure Medical Limited. The 510(k) number is K252309.

When was PerQseal Introducers approved by the FDA?

PerQseal Introducers received FDA 510(k) clearance on 2025-10-23, under approval number K252309.

What company makes PerQseal Introducers?

PerQseal Introducers is manufactured by Vivasure Medical Limited.

What is the FDA product code for PerQseal Introducers?

The FDA product code for PerQseal Introducers is DYB.

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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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