Cleared Traditional

K893041 - NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI

K893041 is an FDA 510(k) clearance for NEW ADHESIVE, manufactured by Telectronics Pacing Systems, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K893041 · Telectronics Pacing Systems, Inc. · Cardiovascular device
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Nov 1989
Decision
204d
Days
Class 3
Risk

K893041 is an FDA 510(k) clearance for the NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Telectronics Pacing Systems, Inc. (Englewood, US). The FDA issued a Cleared decision on November 14, 1989 after a review of 204 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 Pacing Systems, Inc. devices

FDA 510(k) Submission Details - K893041

510(k) Number K893041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1989
Decision Date November 14, 1989
Days to Decision 204 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
79d slower than avg
Panel avg: 125d · This submission: 204d
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 420
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K893041.
FIVE-YEAR STERILE PACKAGING SHELF LIFE
K892528 · Daig Corp. · Jan 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
K895447 · Pacesetter Systems · Dec 1989
MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS
K896443 · Possis Medical, Inc. · Dec 1989
MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS
K885175 · Possis Medical, Inc. · Jul 1989
MODELS 1113 AND 1114 PACEMAKER LEADS
K893763 · Possis Medical, Inc. · Jul 1989
IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR
K894040 · Medtronic Vascular · Jul 1989