Cleared Traditional

K914489 - NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING

K914489 is an FDA 510(k) clearance for NEW EXTRUSION VENDOR FOR POLYURETHANE T..., 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 314-day FDA review.

K914489 · Telectronics Pacing Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 1992
Decision
314d
Days
Class 3
Risk

K914489 is an FDA 510(k) clearance for the NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING. 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 August 17, 1992 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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 - K914489

510(k) Number K914489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1991
Decision Date August 17, 1992
Days to Decision 314 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 125d · This submission: 314d
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 K914489.
MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD
K922972 · Intermedics, Inc. · Jan 1993
MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING
K915736 · Medtronic Vascular · Dec 1992
MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD
K915188 · Cook Pacemaker Corp. · Sep 1992
MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS
K921124 · Medtronic Vascular · May 1992
PERMANENT CARDIAC PACING LEADS AND ADAPTORS
K912464 · Medtronic Vascular · Feb 1992
OSCOR MEDICAL CORP PERMANENT PACING LEAD
K912867 · Oscor Medical Corp. · Feb 1992