Cleared Traditional

K811539 - CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL

K811539 is an FDA 510(k) clearance for CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL, manufactured by Cordis Corp.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 30-day FDA review.

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

FDA 510(k) Submission Details - K811539

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.

DTB Device Classification - Class 3, Premarket Approval

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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K811539.
MODEL C UNIPOLAR ENDOCARDIAL LEAD
K811877 · Cook Pacemaker Corp. · Aug 1981
MODEL B BIPOLAR ENDOCARDIAL LEAD
K811878 · Cook Pacemaker Corp. · Aug 1981
MODEL A UNIPOLAR ENDOCARDIAL LEAD
K811879 · Cook Pacemaker Corp. · Aug 1981
INTERMEDICS POLY FLEX ENDOCARDIAL PACING
K811106 · Intermedics, Inc. · May 1981
TYPE YC ENDOCARDIAL LEAD
K810491 · Biotronik Sales, Inc. · Mar 1981
TYPE YR ENDOCARDIAL LEAD
K810492 · Biotronik Sales, Inc. · Mar 1981