Cleared Traditional

K841227 - BIPOLAR ENDOCARDIAL LEAD 406L

K841227 is an FDA 510(k) clearance for BIPOLAR ENDOCARDIAL LEAD 406L, manufactured by Siemens Elema AB. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K841227 · Siemens Elema AB · Cardiovascular device
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Nov 1984
Decision
250d
Days
Class 2
Risk

K841227 is an FDA 510(k) clearance for the BIPOLAR ENDOCARDIAL LEAD 406L. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Siemens Elema AB (Mchenry, US). The FDA issued a Cleared decision on November 27, 1984 after a review of 250 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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: Standard predicate-based submission. Standard predicate reliance. 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 Siemens Elema AB devices

FDA 510(k) Submission Details - K841227

510(k) Number K841227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1984
Decision Date November 27, 1984
Days to Decision 250 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
125d slower than avg
Panel avg: 125d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTD Device Classification - Class 2, Special Controls

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTD Pacemaker Lead Adaptor

All 85
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K841227.
EPICARDIAL, UNIPOLAR LEAD 4951
K842065 · Medtronic Vascular · Jan 1985
TRANSVENOUS TINED VENTRICULAR LEAD
K842145 · Medtronic Vascular · Jan 1985
PERMATHANE 865 & 867 UNIPOLAR POLYURETH
K843703 · Pacesetter Systems · Jan 1985
SENTRA
K843060 · Cardiac Pacemakers, Inc. · Sep 1984
MODEL 866 PERMATHANE BIPOLAR, COAXIAL
K841739 · Pacesetter Systems · Aug 1984
FASTPASS IMPLANTABLE ENDOCARDIAL PAC
K841885 · Pacesetter Systems · Aug 1984