Cleared Traditional

K843703 - PERMATHANE 865 & 867 UNIPOLAR POLYURETH

K843703 is an FDA 510(k) clearance for PERMATHANE 865 & 867 UNIPOLAR POLYURETH, manufactured by Pacesetter Systems. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K843703 · Pacesetter Systems · Cardiovascular device
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Jan 1985
Decision
109d
Days
Class 2
Risk

K843703 is an FDA 510(k) clearance for the PERMATHANE 865 & 867 UNIPOLAR POLYURETH. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on January 8, 1985 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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: Standard predicate-based submission. Standard predicate reliance. 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

FDA 510(k) Submission Details - K843703

510(k) Number K843703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1984
Decision Date January 08, 1985
Days to Decision 109 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
16d faster than avg
Panel avg: 125d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTD Device Classification - Class 2, Special Controls

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTD Pacemaker Lead Adaptor

All 96
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K843703.
MEDTRONIC MODEL 6912
K844687 · Medtronic Vascular · Feb 1985
EPICARDIAL, UNIPOLAR LEAD 4951
K842065 · Medtronic Vascular · Jan 1985
TRANSVENOUS TINED VENTRICULAR LEAD
K842145 · Medtronic Vascular · Jan 1985
BIPOLAR ENDOCARDIAL LEAD 406L
K841227 · Siemens Elema AB · Nov 1984
SENTRA
K843060 · Cardiac Pacemakers, Inc. · Sep 1984
MODEL 866 PERMATHANE BIPOLAR, COAXIAL
K841739 · Pacesetter Systems · Aug 1984