Cleared Traditional

K861440 - LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/...

K861440 is the FDA 510(k) clearance for LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/... by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K861440 · Pacesetter Systems · Cardiovascular device
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May 1986
Decision
26d
Days
Class 3
Risk

K861440 is an FDA 510(k) clearance for the LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on May 13, 1986 after a review of 26 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 Pacesetter Systems devices

Submission Details

510(k) Number K861440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1986
Decision Date May 13, 1986
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
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 K861440.
MODEL 492-02 ENDOCARDIAL PACING LEAD
K860548 · Intermedics, Inc. · Jun 1986
ENDOCARDIAL CARBON-TIP LEAD
K861481 · Pacesetter Systems · Jun 1986
LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS
K861464 · Pacesetter Systems · May 1986
DJ UNIPOLAR
K853566 · Biotronik Sales, Inc. · May 1986
DJP UNIPOLAR
K853567 · Biotronik Sales, Inc. · May 1986
MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER
K861176 · Intermedics, Inc. · Apr 1986