FDA 510(k)

14F iSLEEVE Introducer Set

K-Number: K230051 · 2023-02-03

Decision Date2023-02-03

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

14F iSLEEVE Introducer Set is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-02-03 under approval number K230051. 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 14F iSLEEVE Introducer Set?

14F iSLEEVE Introducer Set is a medical device that received FDA 510(k) clearance on 2023-02-03. It is manufactured by Boston Scientific Corporation. The 510(k) number is K230051.

When was 14F iSLEEVE Introducer Set approved by the FDA?

14F iSLEEVE Introducer Set received FDA 510(k) clearance on 2023-02-03, under approval number K230051.

What company makes 14F iSLEEVE Introducer Set?

14F iSLEEVE Introducer Set is manufactured by Boston Scientific Corporation.

What is the FDA product code for 14F iSLEEVE Introducer Set?

The FDA product code for 14F 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.