Cleared Traditional

IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET (K851297) - FDA 510(k) Clearance

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

K851297 · Telectronics, Inc. · Cardiovascular device
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Apr 1985
Decision
9d
Days
Class 3
Risk

K851297 is an FDA 510(k) clearance for the IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Suffield, US). The FDA issued a Cleared decision on April 10, 1985 after a review of 9 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 Telectronics, Inc. devices

Submission Details

510(k) Number K851297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date April 10, 1985
Days to Decision 9 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 125d · This submission: 9d
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 K851297.
LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03
K853519 · Intermedics, Inc. · Oct 1985
LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD
K853520 · Intermedics, Inc. · Oct 1985
MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD
K853411 · Intermedics, Inc. · Oct 1985
POLY FLEX IMPLANTABLE PACING LEAD
K802294 · Intermedics, Inc. · Apr 1985
MODEL 486-01 PACEMAKER LEAD
K813135 · Intermedics, Inc. · Apr 1985
MODEL 492-01 PACEMAKER LEAD
K813136 · Intermedics, Inc. · Apr 1985