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SPIRAL FLOW PERIPHERAL VASCULAR GRAFT

K142062 Class II Special
Decision Date
2014-11-20
Sponsor / Applicant
Vascular Flow Technologies, Ltd.

Technical Specification

510(k) Submission ID K142062
Product Code DSY
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.3450
Decision Date 2014-11-20
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SPIRAL FLOW PERIPHERAL VASCULAR GRAFT received FDA 510(k) clearance under submission number K142062, sponsored by Vascular Flow Technologies, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-11-20.

Classification & Regulation

This clearance is catalogued under FDA product code DSY and 21 CFR 870.3450, within the Cardiovascular review panel as a Class II device.