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Prelude SNAP Splittable Sheath Introducer

by Merit Medical Systems, Inc.

510(k) K143255

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK143255 Date9 Apr 2015ClearedStatusActive

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-2574-2024 FDA Class II initiated 11 Jun 2024

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  • 2 recalls, same reason

    • Terminated Z-2239-2021 FDA Class II initiated 30 Jun 2021
    • Terminated Z-2238-2021 FDA Class II initiated 30 Jun 2021

    There is a potential that 7F sheaths are packaged as 10F sheaths.

    • Terminated Z-0688-2018 FDA Class II initiated 14 Dec 2017

    Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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