Accoat Guide Wire— 510(k) K253667

Name: FDA 510(k) clearance K253667
Creator: U.S. Food and Drug Administration
Published: 2026-07-14

Substantially Equivalent

Sp Medical A/S

FDA 510(k) clearance K253667 for Accoat Guide Wire, Substantially Equivalent on 2026-07-14. Applicant: Sp Medical A/S. Device class: 2.

Summary

SP Medical's Accoat Guide Wire is filed under DQX, catheter guide wires. The record doesn't give lengths, diameters, or coating details.

Class II, 21 CFR 870.1330. Cardiovascular is both the classification panel and the review panel, and it was a Traditional 510(k).

SP Medical filed from Karise, Denmark. Review took 235 calendar days (November 21, 2025 to July 14, 2026).

Clearance details

Applicant: Sp Medical A/S
Product code: Product code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2025-11-21
Decision date: 2026-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Karise, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQX

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K253146 — Hyperdrive 35 Guidewire2026-09-18
K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 0352026-09-03
K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire2026-07-13
K254137 — InQwire Amplatz Guide Wire2026-05-22

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.