Cleared Traditional

TYPE FH ENDOCARDIAL LEAD (K810494) - FDA 510(k) Clearance

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

K810494 · Biotronik Sales, Inc. · Cardiovascular device
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Aug 1981
Decision
164d
Days
Class 3
Risk

K810494 is an FDA 510(k) clearance for the TYPE FH ENDOCARDIAL LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Biotronik Sales, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1981 after a review of 164 days - an extended review 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 Biotronik Sales, Inc. devices

Submission Details

510(k) Number K810494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1981
Decision Date August 07, 1981
Days to Decision 164 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 125d · This submission: 164d
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 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K810494.
MEDTRONIC #4951
K812599 · Medtronic Vascular · Oct 1981
INTERMEDICS POLY FLEX EPICARDIAL SUTURE
K812221 · Intermedics, Inc. · Oct 1981
INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL
K812245 · Intermedics, Inc. · Oct 1981
CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL
K811539 · Cordis Corp. · Jul 1981
INTERMEDICS POLY FLEX ENDOCARDIAL PACING
K811106 · Intermedics, Inc. · May 1981
TEMPORARY MYOCARDIAL PACING LEAD#6400
K810333 · Medtronic Vascular · Mar 1981