FDA 510(k)

iSLEEVE Introducer Set

K-Number: K250468 · 2025-03-20

Decision Date2025-03-20

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

iSLEEVE Introducer Set is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2025-03-20 under 510(k) 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. The listed applicant is Boston Scientific. The 510(k) number is K250468.

When did iSLEEVE Introducer Set receive FDA 510(k) clearance?

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

Who is the listed applicant for iSLEEVE Introducer Set?

The FDA 510(k) record lists Boston Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iSLEEVE Introducer Set?

The FDA product code for iSLEEVE Introducer Set is DYB.

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Related Devices (Code: 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.