SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D— 510(k) K001454

Name: FDA 510(k) clearance K001454
Creator: U.S. Food and Drug Administration
Published: 2000-06-07

Substantially Equivalent

Micro Therapeutics, Inc.

FDA 510(k) clearance K001454 for SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D, Substantially Equivalent on 2000-06-07. Applicant: Micro Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Micro Therapeutics, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2000-05-09
Decision date: 2000-06-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQX

view all

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 Micro Therapeutics, Inc.

view all

K113289 — ORION MICRO CATHETER2012-08-01
K113454 — 14 WIRE STANDARD, 14 WIRE LS2012-02-24
K090870 — ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY2009-05-01
K090046 — CONCERTO DETACHABLE COIL SYSTEM2009-02-27
K081465 — AXIUM DETACHABLE COIL SYSTEM2008-08-19

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.