Cleared Traditional

K832987 - PERMANTHANE #866 BIPOLAR COAXIAL

K832987 is the FDA 510(k) clearance for PERMANTHANE #866 BIPOLAR COAXIAL by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K832987 · Pacesetter Systems · Cardiovascular device
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Oct 1983
Decision
49d
Days
Class 3
Risk

K832987 is an FDA 510(k) clearance for the PERMANTHANE #866 BIPOLAR COAXIAL. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Mchenry, US). The FDA issued a Cleared decision on October 20, 1983 after a review of 49 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 K832987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1983
Decision Date October 20, 1983
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 K832987.
ELECTRODE LEAD CONSTRUCTION
K834533 · Telectronics, Inc. · Jan 1984
ENDOCARDIAL SCREW-IN LEAD 859 & 861
K833824 · Pacesetter Systems · Dec 1983
IMPLANTABLE ENDOCARDIAL PACING LEADS
K831997 · Oscor, Inc. · Oct 1983
BIOTRONIK N, BIPOLAR PEB-60/4-N
K833099 · Biotronik Sales, Inc. · Oct 1983
BIOTRONIK DFH UNIPOLAR PE-60/4-DFH
K833106 · Biotronik Sales, Inc. · Oct 1983
BIOTRONIK DN UNIPOLAR PE-60/4-DN &
K833098 · Biotronik Sales, Inc. · Oct 1983