HYDROTORQUE GUIDE WIRE— 510(k) K935232

Name: FDA 510(k) clearance K935232
Creator: U.S. Food and Drug Administration
Published: 1994-07-20

Substantially Equivalent

Kingston Technologies, Inc.

FDA 510(k) clearance K935232 for HYDROTORQUE GUIDE WIRE, Substantially Equivalent on 1994-07-20. Applicant: Kingston Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Kingston Technologies, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 1993-11-01
Decision date: 1994-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQX

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K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 0352026-09-03
K253667 — Accoat Guide Wire2026-07-14
K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire2026-07-13
K254137 — InQwire Amplatz Guide Wire2026-05-22
K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

More clearances from Kingston Technologies, Inc.

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K940814 — HYDRO-M(TM) WOUND GEL1994-05-12
K940738 — KTI HY-Q(TM) WOUND DRESSING1994-05-06
K925660 — KTI TRANSPARENT WOUND DRESSING1993-04-20
K921502 — HYSORB WOUND DRESSING1992-09-29
K882157 — PANAMEX(TM) URETERAL STENT1988-08-02

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.