SARNS TEMPERATURE PROBE AND CONNECTOR— 510(k) K905686

Name: FDA 510(k) clearance K905686
Creator: U.S. Food and Drug Administration
Published: 1991-02-25

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K905686 for SARNS TEMPERATURE PROBE AND CONNECTOR, Substantially Equivalent on 1991-02-25. Applicant: 3M Health Care, Sarns. Device class: 2.

Clearance details

Applicant: 3M Health Care, Sarns
Product code: Code DWE
Device class: Class 2
Regulation: 21 CFR 870.4390
Advisory panel: Cardiovascular
Date received: 1990-12-19
Decision date: 1991-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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K941653 — SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION1994-08-24
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Adverse events under product code DWE

product code DWE

Death: 9
Malfunction: 754
Total: 763

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.