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VASCU-GUARD Peripheral Vascular Patch

K142461 Class II Traditional
Decision Date
2014-11-25
Sponsor / Applicant
Synovis Life Technologies, Inc.

Technical Specification

510(k) Submission ID K142461
Product Code DXZ
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.3470
Decision Date 2014-11-25
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

VASCU-GUARD Peripheral Vascular Patch received FDA 510(k) clearance under submission number K142461, sponsored by Synovis Life Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-11-25.

Classification & Regulation

This clearance is catalogued under FDA product code DXZ and 21 CFR 870.3470, within the Cardiovascular review panel as a Class II device.