510(k) clearance

35 Helix Guidewire

FDA 510(k) source

510(k) number

K260751

Applicant

Piraeus Medical, Inc.

Decision date

Aug 27, 2026

Date received

Mar 6, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MOF

Device type

Guide, Wire, Catheter, Neurovasculature

Device class

Class II

Regulation

21 CFR 870.1330

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Maple Grove, MN, US