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FDA 510(k)

BNLE Access Guidewire

K-Number: K221390 · 2023-04-28

ApplicantBiomerics Nle
Decision Date2023-04-28
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BNLE Access Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Biomerics Nle. It received FDA 510(k) clearance on 2023-04-28 under 510(k) number K221390. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BNLE Access Guidewire?

BNLE Access Guidewire is a medical device that received FDA 510(k) clearance on 2023-04-28. The listed applicant is Biomerics Nle. The 510(k) number is K221390.

When did BNLE Access Guidewire receive FDA 510(k) clearance?

BNLE Access Guidewire received FDA 510(k) clearance on 2023-04-28, under 510(k) number K221390.

Who is the listed applicant for BNLE Access Guidewire?

The FDA 510(k) record lists Biomerics Nle as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BNLE Access Guidewire?

The FDA product code for BNLE Access Guidewire is DQX.

Other records listing Biomerics Nle as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232662BNLE Hydrophilic Jacketed Peripheral Guidewire

Related Devices (Code: DQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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