Cleared Traditional

K861481 - ENDOCARDIAL CARBON-TIP LEAD

K861481 is the FDA 510(k) clearance for ENDOCARDIAL CARBON-TIP LEAD by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K861481 · Pacesetter Systems · Cardiovascular device
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Jun 1986
Decision
45d
Days
Class 3
Risk

K861481 is an FDA 510(k) clearance for the ENDOCARDIAL CARBON-TIP LEAD. 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 June 6, 1986 after a review of 45 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 K861481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1986
Decision Date June 06, 1986
Days to Decision 45 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
80d faster than avg
Panel avg: 125d · This submission: 45d
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 K861481.
CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD
K860846 · Cordis Corp. · Jun 1986
MODEL 486-02 ENDOCARDIAL PACING LEAD
K860547 · Intermedics, Inc. · Jun 1986
MODEL 492-02 ENDOCARDIAL PACING LEAD
K860548 · Intermedics, Inc. · Jun 1986
LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS
K861464 · Pacesetter Systems · May 1986
LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO
K861440 · Pacesetter Systems · May 1986
DJ UNIPOLAR
K853566 · Biotronik Sales, Inc. · May 1986