GUIDEWIRE— 510(k) K982559

Name: FDA 510(k) clearance K982559
Creator: U.S. Food and Drug Administration
Published: 1999-02-01

Substantially Equivalent

Galt Medical Corp.

FDA 510(k) clearance K982559 for GUIDEWIRE, Substantially Equivalent on 1999-02-01. Applicant: Galt Medical Corp.. Device class: 2.

Clearance details

Applicant: Galt Medical Corp.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 1998-07-23
Decision date: 1999-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garland, TX, 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 Galt Medical Corp.

view all

K192195 — Sterile Dilator2019-09-26
K182660 — GaltTWS2019-05-30
K173287 — Elite HV Radial2017-12-21
K172487 — Coaxial Dilator Set (Micro-Introducer)2017-10-16
K153533 — Tearaway Introducer Sheath, MicroSlide Tearaway Introducer2016-07-05

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 →

Recalls naming K982559

K-number listed on FDA's recall record

Z-1734-2025 — GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.Class II·Ongoing·Galt Medical Corporation·20250327

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982559.

Data sourced from openFDA. This site is unofficial and independent of the FDA.