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LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP

K903927 Class III Traditional
Decision Date
1990-10-16
Sponsor / Applicant
Biotronik, GmbH & Co.

Technical Specification

510(k) Submission ID K903927
Product Code DTB
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.3680
Decision Date 1990-10-16
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP received FDA 510(k) clearance under submission number K903927, sponsored by Biotronik, GmbH & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1990-10-16.

Classification & Regulation

This clearance is catalogued under FDA product code DTB and 21 CFR 870.3680, within the Cardiovascular review panel as a Class III device.