FDA 510(k)

BNLE Access Guidewire

K-Number: K221390 · 2023-04-28

Decision Date2023-04-28

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BNLE Access Guidewire is a medical device manufactured by Biomerics Nle. It received FDA 510(k) clearance on 2023-04-28 under approval 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. It is manufactured by Biomerics Nle. The 510(k) number is K221390.

When was BNLE Access Guidewire approved by the FDA?

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

What company makes BNLE Access Guidewire?

BNLE Access Guidewire is manufactured by Biomerics Nle.

What is the FDA product code for BNLE Access Guidewire?

The FDA product code for BNLE Access Guidewire is DQX.

Related Clinical Trials

NCT07515040 Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- Guidance RECRUITING

Other Devices by Biomerics Nle

K232662BNLE Hydrophilic Jacketed Peripheral Guidewire

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Official Source

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