510(k) K232662

BNLE Hydrophilic Jacketed Peripheral Guidewire by Biomerics Nle — Product Code DQX

K232662 is an FDA 510(k) premarket notification submitted by Biomerics Nle for the device "BNLE Hydrophilic Jacketed Peripheral Guidewire". The FDA issued a decision of Substantially Equivalent on May 14, 2024. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Biomerics Nle has at least 1 other 510(k) clearance on record.