Cleared Traditional

K843703 - PERMATHANE 865 & 867 UNIPOLAR POLYURETH

K843703 is the FDA 510(k) clearance for PERMATHANE 865 & 867 UNIPOLAR POLYURETH by Pacesetter Systems. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 84
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