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iSleeve Introducer Set

by Boston Scientific 4 variants

510(k) K202584

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202584↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK202584 Date6 Oct 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
DYB
FDA applicant
Boston Scientific Corporation
Device class
Class II
Regulation
21 CFR Part 870.1340
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The iSleeve Introducer Set is a low-profile vascular introducer designed for transcatheter aortic valve implantation (TAVI) procedures. It facilitates access to smaller and more complex vasculature, enabling physicians to navigate challenging anatomical sites during endovascular interventions.

This set is intended for use by experienced interventional cardiologists familiar with endovascular techniques. Supplied as a sterile, single-use device, it is cleared under FDA 510(k) (K202584) and MDR, with a product code of DYB. Storage and handling must comply with standard sterile medical device protocols.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of procedures is the iSleeve Introducer Set specifically designed for, and why is it considered low-profile?

    The iSleeve Introducer Set is designed for transcatheter aortic valve implantation (TAVI) procedures, where it helps physicians access smaller or more complex blood vessels. Its 'low-profile' design refers to its compact size, which reduces the risk of vessel trauma and makes it easier to navigate through challenging anatomical sites during endovascular interventions.

  • Is the iSleeve Introducer Set reusable, or is it meant for single-use only? How should it be stored?

    The iSleeve Introducer Set is sterile and intended for single-use only. Like all sterile medical devices, it must be stored according to standard protocols to maintain sterility—typically in a sealed, dry environment away from direct sunlight or extreme temperatures until use.

  • How do I know if this device is appropriate for my practice, given its intended user expertise?

    The iSleeve Introducer Set is cleared for use by experienced interventional cardiologists familiar with endovascular techniques. It is not intended for general vascular access but specifically for TAVI procedures, so its suitability depends on whether your practice performs such complex interventions.

  • What regulatory pathways does the iSleeve Introducer Set follow, and what does the product code (DYB) indicate?

    The device follows FDA 510(k) clearance (K202584) and EU MDR compliance, with a product code of DYB, which categorizes it under vascular introducers. The clearance type is marked as 'Special,' and it was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee as substantially equivalent to a predicate device.