BNLE Access Guidewire— 510(k) K221390

Name: FDA 510(k) clearance K221390
Creator: U.S. Food and Drug Administration
Published: 2023-04-28

Substantially Equivalent

Biomerics Nle

FDA 510(k) clearance K221390 for BNLE Access Guidewire, Substantially Equivalent on 2023-04-28. Applicant: Biomerics Nle. Device class: 2.

Clearance details

Applicant: Biomerics Nle
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2022-05-13
Decision date: 2023-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn Park, MN, 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

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K232662 — BNLE Hydrophilic Jacketed Peripheral Guidewire2024-05-14

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.