Cleared Traditional

K811876 - MODEL D BIPOLAR ENDOCARDIAL LEAD

K811876 is the FDA 510(k) clearance for MODEL D BIPOLAR ENDOCARDIAL LEAD by Cook Pacemaker Corp.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K811876 · Cook Pacemaker Corp. · Cardiovascular device
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Aug 1981
Decision
33d
Days
Class 3
Risk

K811876 is an FDA 510(k) clearance for the MODEL D BIPOLAR ENDOCARDIAL LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Cook Pacemaker Corp. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1981 after a review of 33 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 Cook Pacemaker Corp. devices

Submission Details

510(k) Number K811876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1981
Decision Date August 03, 1981
Days to Decision 33 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
92d faster than avg
Panel avg: 125d · This submission: 33d
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 386
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K811876.
INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL
K812245 · Intermedics, Inc. · Oct 1981
PACEPATH IMPLANTABLE ENDOCARD. PACING LD
K811200 · Pacesetter Systems · Aug 1981
TYPE FH ENDOCARDIAL LEAD
K810494 · Biotronik Sales, Inc. · Aug 1981
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