Hyperdrive 35 Guidewire— 510(k) K253146

Name: FDA 510(k) clearance K253146
Creator: U.S. Food and Drug Administration
Published: 2026-09-18

Substantially Equivalent

Rapid-Medical , Ltd.

FDA 510(k) clearance K253146 for Hyperdrive 35 Guidewire, Substantially Equivalent on 2026-09-18. Applicant: Rapid-Medical , Ltd.. Device class: 2.

Summary

Hyperdrive 35 Guidewire is from Rapid-Medical, Ltd., filed under product code DQX (Wire, Guide, Catheter). The record doesn't describe the guidewire beyond its name and code.

Class II, 21 CFR 870.1330. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.

Rapid-Medical filed from Yokneam, Israel. The decision came 358 calendar days after FDA received it (September 25, 2025 to September 18, 2026). The record flags it as a third-party review.

Clearance details

Applicant: Rapid-Medical , Ltd.
Product code: Product code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2025-09-25
Decision date: 2026-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

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 Rapid-Medical , Ltd.

view all

K260617 — Tigertriever 13 Ultra Revascularization Device2026-08-28
K254006 — Drivewire 35 Guidewire2026-07-17
K253062 — Tigertriever 25 Revascularization Device2026-03-12
K251603 — Tigertriever 17 Ultra Revascularization Device2025-10-06
K233791 — Drivewire 24 Guidewire2024-07-11

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.