SUNMED GUIDE WIRE— 510(k) K120119

Name: FDA 510(k) clearance K120119
Creator: U.S. Food and Drug Administration
Published: 2012-05-11

Substantially Equivalent

Sunny Medical Device (Shenzhen) Co., Ltd.

FDA 510(k) clearance K120119 for SUNMED GUIDE WIRE, Substantially Equivalent on 2012-05-11. Applicant: Sunny Medical Device (Shenzhen) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sunny Medical Device (Shenzhen) Co., Ltd.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2012-01-17
Decision date: 2012-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K254137 — InQwire Amplatz Guide Wire2026-05-22
K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

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K153685 — Sunmed Haemostatic Valves2016-10-13
K140356 — SUMMED HIGH PRESSURE LINE2015-03-20
K133795 — SUMMED INFLATION DEVICE KIT2014-12-12

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.