Cleared Traditional

K852709 - IMPLANT ELECT LEAD

K852709 is an FDA 510(k) clearance for IMPLANT ELECT LEAD, manufactured by Telectronics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K852709 · Telectronics, Inc. · Cardiovascular device
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Sep 1985
Decision
83d
Days
Class 3
Risk

K852709 is an FDA 510(k) clearance for the IMPLANT ELECT LEAD, MOD 30-403 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 September 17, 1985 after a review of 83 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

FDA 510(k) Submission Details - K852709

510(k) Number K852709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1985
Decision Date September 17, 1985
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

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 387
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K852709.
LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD
K853520 · Intermedics, Inc. · Oct 1985
IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A
K852708 · Telectronics, Inc. · Oct 1985
MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD
K853411 · Intermedics, Inc. · Oct 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401
K853221 · Telectronics, Inc. · Sep 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402
K853222 · Telectronics, Inc. · Sep 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407
K853223 · Telectronics, Inc. · Sep 1985