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WEXLER VASCULAR CLAMP SERIES

K110148 Class II Traditional
Decision Date
2011-04-19
Sponsor / Applicant
Microsurgical Laboratories,Inc.Dba Wexler Surgical

Technical Specification

510(k) Submission ID K110148
Product Code DXC
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.4450
Decision Date 2011-04-19
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

WEXLER VASCULAR CLAMP SERIES received FDA 510(k) clearance under submission number K110148, sponsored by Microsurgical Laboratories,Inc.Dba Wexler Surgical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-04-19.

Classification & Regulation

This clearance is catalogued under FDA product code DXC and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.