TECHDEVICE OCCLUSION BALLOON CATHETER— 510(k) K051137

Name: FDA 510(k) clearance K051137
Creator: U.S. Food and Drug Administration
Published: 2006-02-24

Substantially Equivalent

Techdevice Corporation

FDA 510(k) clearance K051137 for TECHDEVICE OCCLUSION BALLOON CATHETER, Substantially Equivalent on 2006-02-24. Applicant: Techdevice Corporation. Device class: 2.

Clearance details

Applicant: Techdevice Corporation
Product code: Code MJN
Device class: Class 2
Regulation: 21 CFR 870.4450
Advisory panel: Cardiovascular
Date received: 2005-05-04
Decision date: 2006-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

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K214060 — LANDMARK REBOA Catheter2022-09-19
K211610 — Fogarty Occlusion Catheter2022-02-14

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K053028 — TECHDEVICE GUIDEWIRE2006-01-31

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.