FDA 510(k)

15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set

K-Number: K191871 · 2019-08-07

Decision Date2019-08-07

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-08-07 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K191871.

When did 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set receive FDA 510(k) clearance?

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

Who is the listed applicant for 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set?

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

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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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.