FDA 510(k)

BNLE Hydrophilic Jacketed Peripheral Guidewire

K-Number: K232662 · 2024-05-14

Decision Date2024-05-14

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BNLE Hydrophilic Jacketed Peripheral Guidewire is a medical device manufactured by Biomerics Nle. It received FDA 510(k) clearance on 2024-05-14 under approval number K232662. 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 Hydrophilic Jacketed Peripheral Guidewire?

BNLE Hydrophilic Jacketed Peripheral Guidewire is a medical device that received FDA 510(k) clearance on 2024-05-14. It is manufactured by Biomerics Nle. The 510(k) number is K232662.

When was BNLE Hydrophilic Jacketed Peripheral Guidewire approved by the FDA?

BNLE Hydrophilic Jacketed Peripheral Guidewire received FDA 510(k) clearance on 2024-05-14, under approval number K232662.

What company makes BNLE Hydrophilic Jacketed Peripheral Guidewire?

BNLE Hydrophilic Jacketed Peripheral Guidewire is manufactured by Biomerics Nle.

What is the FDA product code for BNLE Hydrophilic Jacketed Peripheral Guidewire?

The FDA product code for BNLE Hydrophilic Jacketed Peripheral Guidewire is DQX.

Other Devices by Biomerics Nle

K221390BNLE Access Guidewire

Related Devices (Code: DQX)

K160785Worker GuidewireArgon Medical Devices, Inc. K161702Endura guidewireVascular Solutions, Inc. K160594MRWire Guide WireNano4imaging GmbH K160643ENROUTE 0.014 GuidewireLake Region Medical K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd. K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.

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.