MSI PRESSURE INFUSOR— 510(k) K973843

Name: FDA 510(k) clearance K973843
Creator: U.S. Food and Drug Administration
Published: 1997-10-29

Substantially Equivalent

Smith Assoc.

FDA 510(k) clearance K973843 for MSI PRESSURE INFUSOR, Substantially Equivalent on 1997-10-29. Applicant: Smith Assoc.. Device class: 1.

Clearance details

Applicant: Smith Assoc.
Product code: Code KZD
Device class: Class 1
Regulation: 21 CFR 880.5420
Advisory panel: General Hospital
Date received: 1997-10-08
Decision date: 1997-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KZD

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K974074 — INFUSION DYNAMICS POWER INFUSER1998-02-17
K953290 — OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP1995-10-07
K951988 — PRESSURIZER1995-06-14
K942933 — PRESSURE INFUSION CUFF1994-08-25
K930012 — KAWASUMI LABORATORIES K-CUFF1993-12-14

Adverse events under product code KZD

product code KZD

Death: 4
Total: 4

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.