Cleared Traditional

CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL (K811539) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K811539 · Cordis Corp. · Cardiovascular device
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Jul 1981
Decision
30d
Days
Class 3
Risk

K811539 is an FDA 510(k) clearance for the CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on July 1, 1981 after a review of 30 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 Cordis Corp. devices

Submission Details

510(k) Number K811539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1981
Decision Date July 01, 1981
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 221
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K811539.
ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J
K811593 · Telectronics, Inc. · Oct 1981
INTERMEDICS POLY FLEX EPICARDIAL SUTURE
K812221 · Intermedics, Inc. · Oct 1981
INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL
K812245 · Intermedics, Inc. · Oct 1981
INTERMEDICS POLY FLEX ENDOCARDIAL PACING
K811106 · Intermedics, Inc. · May 1981
TEMPORARY MYOCARDIAL PACING LEAD#6400
K810333 · Medtronic Vascular · Mar 1981
CORDIS PERVENOUS ATRIAL LEAD
K810432 · Cordis Corp. · Mar 1981