Cleared Traditional

IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A (K852708) - FDA 510(k) Clearance

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

K852708 · Telectronics, Inc. · Cardiovascular device
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Oct 1985
Decision
97d
Days
Class 3
Risk

K852708 is an FDA 510(k) clearance for the IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A. 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 October 1, 1985 after a review of 97 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 Telectronics, Inc. devices

Submission Details

510(k) Number K852708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1985
Decision Date October 01, 1985
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
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 K852708.
LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-06
K853518 · Intermedics, Inc. · Nov 1985
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