Not Cleared Traditional

STELA MODEL BJ44 AND BJ45 PACING LEADS (K963738) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

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

K963738 is an FDA 510(k) submission (not cleared) for the STELA MODEL BJ44 AND BJ45 PACING LEADS. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Not Cleared (DENG) decision on May 23, 1997 after a review of 248 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

View all Ela Medical, Inc. devices

Submission Details

510(k) Number K963738 FDA.gov
FDA Decision Not Cleared PT (PT)
Date Received September 17, 1996
Decision Date May 23, 1997
Days to Decision 248 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 125d · This submission: 248d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K963738.
MODEL 5071 MYOCARDIAL PACING LEAD
K031274 · Medtronic Vascular · May 2003
MODEL 430-07 ENDOCARDIAL PACING LEAD
K954610 · Intermedics, Inc. · Dec 1996
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
K955122 · Intermedics, Inc. · Nov 1996
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD
K962036 · Medtronic Vascular · Aug 1996
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
K962174 · Intermedics, Inc. · Aug 1996
MODEL 2188 CORONARY SINUS LEAD.
K961936 · Medtronic Vascular · Aug 1996