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FDA 510(k)

15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set

K-Number: K191871 · 2019-08-07

ApplicantBoston Scientific Corporation
Decision Date2019-08-07
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-08-07 under approval number K191871. 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 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set?

15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set is a medical device that received FDA 510(k) clearance on 2019-08-07. It is manufactured by Boston Scientific Corporation. The 510(k) number is K191871.

When was 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set approved by the FDA?

15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set received FDA 510(k) clearance on 2019-08-07, under approval number K191871.

What company makes 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set?

15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set is manufactured by Boston Scientific Corporation.

What is the FDA product code for 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set?

The FDA product code for 15F iSLEEVE Introducer Set, 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.

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