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FDA 510(k)

iSLEEVE Introducer Set

K-Number: K180785 · 2018-06-22

ApplicantBoston Scientific Corporation
Decision Date2018-06-22
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

iSLEEVE Introducer Set is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2018-06-22 under approval number K180785. 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 2018-06-22. It is manufactured by Boston Scientific Corporation. The 510(k) number is K180785.

When was iSLEEVE Introducer Set approved by the FDA?

iSLEEVE Introducer Set received FDA 510(k) clearance on 2018-06-22, under approval number K180785.

What company makes iSLEEVE Introducer Set?

iSLEEVE Introducer Set is manufactured by Boston Scientific Corporation.

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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