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Adult Vent Catheter

by Dlp, Inc. 510(k)

Active United States Open recall

510(k) K834352

Regulatory status

as of 28 Oct 2026

Recall ongoing. 2 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK834352 Date27 Jan 1984ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2504-2021 FDA Class II initiated 24 Aug 2021
    • Ongoing Z-2505-2021 FDA Class II initiated 24 Aug 2021

    Potential for a wire protrusion through the left heart vent catheter tip

Specification

510(k)

510(k) Number
FDA Product Code
DRA
Device Class
Class II
Regulation
21 CFR Part 870.1280
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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