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Venous Perfusion Cannula W/Cuff Cat. No. 94015

by Dlp, Inc. 510(k)

Active United States Open recall

510(k) K860149

Regulatory status

as of 28 Oct 2026

Recall ongoing. 9 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK860149 Date31 Mar 1986ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

9 recalls · 9 ongoing · FDA

  • 9 recalls, same reason

    • Ongoing Z-2218-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2219-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2216-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2214-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2217-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2221-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2222-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2220-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2215-2026 FDA Class II initiated 21 Apr 2026

    Certain lots of product have the potential for a sterile barrier breach.

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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