Not Cleared Traditional

K933055 - MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF

K933055 is an FDA 510(k) submission for MEDTRONIS PACING LEADS AND LEAD ADAPTORS, manufactured by Medtronic Vascular. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K933055 · Medtronic Vascular · Cardiovascular device
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May 1994
Decision
340d
Days
Class 3
Risk

K933055 is an FDA 510(k) submission (not cleared) for the MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Not Cleared (DENG) decision on May 2, 1994 after a review of 340 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 340 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.

FDA 510(k) Submission Details - K933055

510(k) Number K933055 FDA.gov
FDA Decision Not Cleared PT (PT)
Date Received May 27, 1993
Decision Date May 02, 1994
Days to Decision 340 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
215d slower than avg
Panel avg: 125d · This submission: 340d
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 486
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K933055.
PACING LEAD MODEL 1188T
K925038 · Siemens-Pacesetter, Inc. · Jul 1994
PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS
K932892 · Siemens-Pacesetter, Inc. · Jul 1994
SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T
K930876 · Siemens-Pacesetter, Inc. · Jun 1994
MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD
K933731 · Medtronic Vascular · Mar 1994
MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS
K932172 · Medtronic Vascular · Dec 1993
VASCOTWIST 9/60
K920662 · Vascor Medical Corp. · Nov 1993
K933055 · MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF
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