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Prelude Guide Sheath

by Merit Medical Systems, Inc.

510(k) K211405

Prelude Guide Sheath is a medical device (FDA Class II; FDA product code DYB, Introducer, Catheter) made by Merit Medical Systems, Inc., cleared under FDA 510(k) K211405 on 4 Oct 2021, active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211405 Date4 Oct 2021ClearedStatusActive

Official records

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-2218-2024 FDA Class II initiated 22 May 2024

    Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.

  • 2 recalls, same reason

    • Ongoing Z-1874-2024 FDA Class II initiated 14 Mar 2024
    • Ongoing Z-1875-2024 FDA Class II initiated 14 Mar 2024

    Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.

Timeline

4 dated events

  1. Cleared FDA 510(k) K211405
  2. Recall initiated FDA recalls Z-1874-2024
  3. Recall initiated FDA recalls Z-1875-2024
  4. Recall initiated FDA recalls Z-2218-2024

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  • Withdrawn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

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code DYB (Introducer, Catheter).

Other devices from Merit Medical Systems, Inc.

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