Cleared Traditional

K954085 - MODELS 5866-45 AND 5866-46 SIZING SLEEVE

K954085 is the FDA 510(k) clearance for MODELS 5866-45 AND 5866-46 SIZING SLEEVE by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K954085 · Medtronic Vascular · Cardiovascular device
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Nov 1995
Decision
71d
Days
Class 3
Risk

K954085 is an FDA 510(k) clearance for the MODELS 5866-45 AND 5866-46 SIZING SLEEVE. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on November 7, 1995 after a review of 71 days - a notably fast clearance cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Vascular devices

Submission Details

510(k) Number K954085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received August 28, 1995
Decision Date November 07, 1995
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
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 364
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K954085.
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
K955550 · Intermedics, Inc. · Jun 1996
IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY
K960281 · Intermedics, Inc. · Jun 1996
INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
K954719 · Intermedics, Inc. · Feb 1996
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS
K951858 · Medtronic Vascular · Oct 1995
MEDTRONIC MODEL 4558M
K940703 · Medtronic Vascular · Nov 1994
MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF
K933055 · Medtronic Vascular · May 1994