Cleared Traditional

K865098 - SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD

K865098 is an FDA 510(k) clearance for SLIMLINE UNIPOLAR ENDOCARDIAL PACING 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 231-day FDA review.

K865098 · Telectronics, Inc. · Cardiovascular device
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Aug 1987
Decision
231d
Days
Class 3
Risk

K865098 is an FDA 510(k) clearance for the SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438. 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 August 18, 1987 after a review of 231 days - an extended review 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 - K865098

510(k) Number K865098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1986
Decision Date August 18, 1987
Days to Decision 231 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
106d slower than avg
Panel avg: 125d · This submission: 231d
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 K865098.
MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD
K870885 · Medtronic Vascular · Nov 1987
MODIFIED MODELS 1025M & 1026T PACING LEAD
K873931 · Pacesetter Systems · Oct 1987
PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860
K872731 · Ela Medical, Inc. · Sep 1987
IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01
K871580 · Intermedics, Inc. · May 1987
IMPLANTABLE ELECTRODE LEAD, MODEL 030-439
K864618 · Telectronics, Inc. · May 1987
ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY
K870357 · Intermedics, Inc. · May 1987