Not Cleared Traditional

UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION (K953044) - FDA 510(k) Clearance

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

K953044 · Biotronik, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
455d
Days
Class 3
Risk

K953044 is an FDA 510(k) submission (not cleared) for the UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER.... Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Not Cleared (DENG) decision on September 27, 1996 after a review of 455 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: Regulatory edge-case submission. High predicate equivalence gap. With 455 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Biotronik, Inc. devices

Submission Details

510(k) Number K953044 FDA.gov
FDA Decision Not Cleared PT (PT)
Date Received June 30, 1995
Decision Date September 27, 1996
Days to Decision 455 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
330d slower than avg
Panel avg: 125d · This submission: 455d
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 486
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K953044.
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