MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)— 510(k) K954284

Name: FDA 510(k) clearance K954284
Creator: U.S. Food and Drug Administration
Published: 1996-02-12

Substantially Equivalent

Medi-Plast Intl., Inc.

FDA 510(k) clearance K954284 for MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON), Substantially Equivalent on 1996-02-12. 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: 1995-08-30
Decision date: 1996-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck,, NY, US

Download summary PDF View on FDA.gov ↗

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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.