Not Cleared Traditional

K954610 - MODEL 430-07 ENDOCARDIAL PACING LEAD

K954610 is an FDA 510(k) submission for MODEL 430-07 ENDOCARDIAL PACING LEAD, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 439-day FDA review.

K954610 · Intermedics, Inc. · Cardiovascular device
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Dec 1996
Decision
439d
Days
Class 3
Risk

K954610 is an FDA 510(k) submission (not cleared) for the MODEL 430-07 ENDOCARDIAL PACING LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Angleton, US). The FDA issued a Not Cleared (DENG) decision on December 16, 1996 after a review of 439 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 439 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K954610

510(k) Number K954610 FDA.gov
FDA Decision Not Cleared PT (PT)
Date Received October 04, 1995
Decision Date December 16, 1996
Days to Decision 439 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
314d slower than avg
Panel avg: 125d · This submission: 439d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K954610.
STELA MODEL BJ44 AND BJ45 PACING LEADS
K963738 · Ela Medical, Inc. · May 1997
OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR
K964107 · Oscor Medical Corp. · Apr 1997
BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION
K964604 · Biotronik, Inc. · Mar 1997
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
K955122 · Intermedics, Inc. · Nov 1996
UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION
K953044 · Biotronik, Inc. · Sep 1996
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD
K962036 · Medtronic Vascular · Aug 1996