Cleared Traditional

K895447 - ENDOCARDIAL SCREW-IN LEAD MODEL 1020T

K895447 is an FDA 510(k) clearance for ENDOCARDIAL SCREW-IN LEAD MODEL 1020T, manufactured by Pacesetter Systems. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K895447 · Pacesetter Systems · Cardiovascular device
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Dec 1989
Decision
103d
Days
Class 3
Risk

K895447 is an FDA 510(k) clearance for the ENDOCARDIAL SCREW-IN LEAD MODEL 1020T. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on December 20, 1989 after a review of 103 days - within the typical 510(k) review window.

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 Pacesetter Systems devices

FDA 510(k) Submission Details - K895447

510(k) Number K895447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1989
Decision Date December 20, 1989
Days to Decision 103 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
22d faster than avg
Panel avg: 125d · This submission: 103d
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 423
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K895447.
PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA
K895136 · Medtronic Vascular · Feb 1990
MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES
K897067 · Telectronics Pacing Systems, Inc. · Feb 1990
FIVE-YEAR STERILE PACKAGING SHELF LIFE
K892528 · Daig Corp. · Jan 1990
MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS
K896443 · Possis Medical, Inc. · Dec 1989
NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI
K893041 · Telectronics Pacing Systems, Inc. · Nov 1989
MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS
K885175 · Possis Medical, Inc. · Jul 1989