Cleared Traditional

K841739 - MODEL 866 PERMATHANE BIPOLAR, COAXIAL

K841739 is an FDA 510(k) clearance for MODEL 866 PERMATHANE BIPOLAR, 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 98-day FDA review.

K841739 · Pacesetter Systems · Cardiovascular device
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Aug 1984
Decision
98d
Days
Class 2
Risk

K841739 is an FDA 510(k) clearance for the MODEL 866 PERMATHANE BIPOLAR, COAXIAL. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Pacesetter Systems (Mchenry, US). The FDA issued a Cleared decision on August 3, 1984 after a review of 98 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 - K841739

510(k) Number K841739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1984
Decision Date August 03, 1984
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
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 K841739.
PERMATHANE 865 & 867 UNIPOLAR POLYURETH
K843703 · Pacesetter Systems · Jan 1985
BIPOLAR ENDOCARDIAL LEAD 406L
K841227 · Siemens Elema AB · Nov 1984
SENTRA
K843060 · Cardiac Pacemakers, Inc. · Sep 1984
FASTPASS IMPLANTABLE ENDOCARDIAL PAC
K841885 · Pacesetter Systems · Aug 1984
IMPLANTABLE ELECTRODE BIPOLAR ADAPT
K840025 · Telectronics, Inc. · May 1984
IMPLANTABLE ELECTRODE UNIPOLAR ADAPT
K840026 · Telectronics, Inc. · May 1984