MEDI-PLAST DISPOSABLE MANIFOLD— 510(k) K863402

Name: FDA 510(k) clearance K863402
Creator: U.S. Food and Drug Administration
Published: 1986-10-22

Substantially Equivalent

Medi-Plast Intl., Inc.

FDA 510(k) clearance K863402 for MEDI-PLAST DISPOSABLE MANIFOLD, Substantially Equivalent on 1986-10-22. Applicant: Medi-Plast Intl., Inc.. Device class: 2.

Clearance details

Applicant: Medi-Plast Intl., Inc.
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
Advisory panel: Cardiovascular
Date received: 1986-09-03
Decision date: 1986-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Medi-Plast Intl., Inc.

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K954284 — MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)1996-02-12
K873588 — 10CC CONTROL SYRINGE1987-10-23
K861785 — FLUOROSCOPE BAND BAG1986-06-13
K851489 — ARTERIAL-VENOUS COMPRESSION DRESSING1985-06-11
K842136 — STERILE PAN SET1984-07-06

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.