Cleared Traditional

K852915 - SLIM VENT UNIPO PACING LEAD USING POLYU 90A

K852915 is an FDA 510(k) clearance for SLIM VENT UNIPO PACING LEAD USING POLYU 90A, 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 35-day FDA review.

K852915 · Telectronics, Inc. · Cardiovascular device
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Jul 1985
Decision
35d
Days
Class 3
Risk

K852915 is an FDA 510(k) clearance for the SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281. 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 July 29, 1985 after a review of 35 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 - K852915

510(k) Number K852915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1985
Decision Date July 29, 1985
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
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 K852915.
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407
K853223 · Telectronics, Inc. · Sep 1985
IMPLANTABLE ELECTRODE LEAD, MODEL 030-400
K852972 · Telectronics, Inc. · Sep 1985
ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860
K851731 · Ela Medical, Inc. · Aug 1985
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE
K851461 · Telectronics, Inc. · Jul 1985
OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE
K850623 · Oscor Medical Corp. · Apr 1985
IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH
K851296 · Telectronics, Inc. · Apr 1985