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HI-TORQUE PROCEED Guide Wire Family

K201834 Class II Special
Decision Date
2020-07-30
Sponsor / Applicant
Abbott Vascular

Technical Specification

510(k) Submission ID K201834
Product Code DQX
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1330
Decision Date 2020-07-30
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

HI-TORQUE PROCEED Guide Wire Family received FDA 510(k) clearance under submission number K201834, sponsored by Abbott Vascular. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-07-30.

Classification & Regulation

This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.