Cleared Traditional

K851296 - IMPLANTABLE ELECTRODE LEAD 030-269 USIN...

K851296 is an FDA 510(k) clearance for IMPLANTABLE ELECTRODE LEAD 030-269 USIN..., 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 10-day FDA review.

K851296 · Telectronics, Inc. · Cardiovascular device
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Apr 1985
Decision
10d
Days
Class 3
Risk

K851296 is an FDA 510(k) clearance for the IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH. 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 11, 1985 after a review of 10 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 - K851296

510(k) Number K851296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date April 11, 1985
Days to Decision 10 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
115d faster than avg
Panel avg: 125d · This submission: 10d
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 K851296.
SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281
K852915 · Telectronics, Inc. · Jul 1985
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE
K851461 · Telectronics, Inc. · Jul 1985
OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE
K850623 · Oscor Medical Corp. · Apr 1985
ELECATH TORKFLOAT PACING PROBE
K850065 · Electro-Catheter Corp. · Apr 1985
IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH
K851294 · Telectronics, Inc. · Apr 1985
IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH
K851295 · Telectronics, Inc. · Apr 1985