PRESSURE INFUSION CUFF— 510(k) K942933

Name: FDA 510(k) clearance K942933
Creator: U.S. Food and Drug Administration
Published: 1994-08-25

Substantially Equivalent

Circulatory Technology, Inc.

FDA 510(k) clearance K942933 for PRESSURE INFUSION CUFF, Substantially Equivalent on 1994-08-25. Applicant: Circulatory Technology, Inc.. Device class: 1.

Clearance details

Applicant: Circulatory Technology, Inc.
Product code: Code KZD
Device class: Class 1
Regulation: 21 CFR 880.5420
Advisory panel: General Hospital
Date received: 1994-06-22
Decision date: 1994-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oyster Bay, NY, US

Download summary PDF View on FDA.gov ↗

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K951988 — PRESSURIZER1995-06-14
K930012 — KAWASUMI LABORATORIES K-CUFF1993-12-14

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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.