Not Cleared Traditional

STELA MODEL BJ44 AND BJ45 PACING LEADS

K963738 · Ela Medical, Inc. · Cardiovascular
May 1997
Decision
248d
Days
Class 3
Risk

About This 510(k) Submission

K963738 is an FDA 510(k) submission for the STELA MODEL BJ44 AND BJ45 PACING LEADS, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Not Cleared (DENG) decision on May 23, 1997. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K963738 FDA.gov
FDA Decision Not Cleared PT
Date Received September 17, 1996
Decision Date May 23, 1997
Days to Decision 248 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DTB — Permanent Pacemaker Electrode
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3680

Similar Devices — DTB Permanent Pacemaker Electrode

All 486
BIOTRONIK ENDOCARDIAL PACING LEADS
K061212 · Biotronik, Inc. · Jul 2006
PERMANENT PACING LEAD, MODEL PY2
K041809 · Oscor, Inc. · Aug 2004
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
K040569 · Oscor, Inc. · Apr 2004
MODEL 5071 MYOCARDIAL PACING LEAD
K031274 · Medtronic Vascular · May 2003
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
K031210 · Metronic, Inc. · May 2003
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
K023205 · Biotronik, Inc. · Apr 2003