Cleared Traditional

K811200 - PACEPATH IMPLANTABLE ENDOCARD. PACING LD

K811200 is the FDA 510(k) clearance for PACEPATH IMPLANTABLE ENDOCARD. PACING LD by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K811200 · Pacesetter Systems · Cardiovascular device
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Aug 1981
Decision
105d
Days
Class 3
Risk

K811200 is an FDA 510(k) clearance for the PACEPATH IMPLANTABLE ENDOCARD. PACING LD. 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 August 13, 1981 after a review of 105 days - within the typical 510(k) review window.

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 K811200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1981
Decision Date August 13, 1981
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
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 K811200.
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
TYPE FH ENDOCARDIAL LEAD
K810494 · Biotronik Sales, Inc. · Aug 1981
MODEL D BIPOLAR ENDOCARDIAL LEAD
K811876 · Cook Pacemaker Corp. · Aug 1981
MODEL C UNIPOLAR ENDOCARDIAL LEAD
K811877 · Cook Pacemaker Corp. · Aug 1981