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FDA 510(k)

iSLEEVE Introducer Set

K-Number: K250468 · 2025-03-20

ApplicantBoston Scientific
Decision Date2025-03-20
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

iSLEEVE Introducer Set is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2025-03-20 under approval number K250468. 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 iSLEEVE Introducer Set?

iSLEEVE Introducer Set is a medical device that received FDA 510(k) clearance on 2025-03-20. It is manufactured by Boston Scientific. The 510(k) number is K250468.

When was iSLEEVE Introducer Set approved by the FDA?

iSLEEVE Introducer Set received FDA 510(k) clearance on 2025-03-20, under approval number K250468.

What company makes iSLEEVE Introducer Set?

iSLEEVE Introducer Set is manufactured by Boston Scientific.

What is the FDA product code for iSLEEVE Introducer Set?

The FDA product code for iSLEEVE Introducer Set 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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