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Infant Vent Catheter 12001 W/Side Vent

by Dlp, Inc. 510(k)

Active United States Open recall

510(k) K834039

Regulatory status

as of 29 Oct 2026

Recall ongoing. 3 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK834039 Date3 Jan 1984ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2481-2025 FDA Class I initiated 6 Aug 2025
    • Ongoing Z-2482-2025 FDA Class I initiated 6 Aug 2025
    • Ongoing Z-2480-2025 FDA Class I initiated 6 Aug 2025

    The catheters may not retain their shape.

Specification

510(k)

510(k) Number
FDA Product Code
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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