DUOFLO CATHETER— 510(k) K080700

Name: FDA 510(k) clearance K080700
Creator: U.S. Food and Drug Administration
Published: 2008-09-26

Substantially Equivalent

Thermopeutix, Inc.

FDA 510(k) clearance K080700 for DUOFLO CATHETER, Substantially Equivalent on 2008-09-26. Applicant: Thermopeutix, Inc.. Device class: 2.

Clearance details

Applicant: Thermopeutix, Inc.
Product code: Code MJN
Device class: Class 2
Regulation: 21 CFR 870.4450
Advisory panel: Cardiovascular
Date received: 2008-03-11
Decision date: 2008-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K132701 — PRIMI SUPPORT CATHETER2013-09-26
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K112219 — TAPAS CATHETER2011-11-18
K093847 — DUFLO CATHETER (HEPARIN COATED)2010-08-25

Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.