INFANT FEEDING TUBE— 510(k) K953008

Name: FDA 510(k) clearance K953008
Creator: U.S. Food and Drug Administration
Published: 1996-01-11

Substantially Equivalent

Marquette Medical, Inc.

FDA 510(k) clearance K953008 for INFANT FEEDING TUBE, Substantially Equivalent on 1996-01-11. Applicant: Marquette Medical, Inc.. Device class: 2.

Clearance details

Applicant: Marquette Medical, Inc.
Product code: Code FPD
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1995-06-28
Decision date: 1996-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Millersville, MD, US

Download summary PDF View on FDA.gov ↗

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K920537 — SUBCUTANEOUS INFUSION SET1992-10-13
K905218 — 4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP1991-06-04
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Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

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.