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POSTERIOR ANNULOPLASTY BAND (MODEL 607)

K960356 Class II Traditional
Decision Date
1996-08-27
Sponsor / Applicant
The Heart Valve Div. Medtronic Cardiovascular Surg

Technical Specification

510(k) Submission ID K960356
Product Code KRH
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.3800
Decision Date 1996-08-27
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

POSTERIOR ANNULOPLASTY BAND (MODEL 607) received FDA 510(k) clearance under submission number K960356, sponsored by The Heart Valve Div. Medtronic Cardiovascular Surg. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1996-08-27.

Classification & Regulation

This clearance is catalogued under FDA product code KRH and 21 CFR 870.3800, within the Cardiovascular review panel as a Class II device.