Cleared Traditional

PACEMAKER LEAD ADAPTER

K890018 · Ela Medical, Inc. · Cardiovascular
Jun 1989
Decision
168d
Days
Class 3
Risk

About This 510(k) Submission

K890018 is an FDA 510(k) clearance for the PACEMAKER LEAD ADAPTER, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on June 20, 1989, 168 days after receiving the submission on January 3, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K890018 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 1989
Decision Date June 20, 1989
Days to Decision 168 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