Not Cleared Traditional

K963738 - STELA MODEL BJ44 AND BJ45 PACING LEADS

K963738 is the FDA 510(k) submission for STELA MODEL BJ44 AND BJ45 PACING LEADS by Ela Medical, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 248-day FDA review.

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
Combination Product No
PCCP Authorized No
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 386
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K963738.
TIR/TIJ AND POLYROX
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