Cleared Traditional

K864153 - PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL...

K864153 is the FDA 510(k) clearance for PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL... by Pace Medical. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K864153 · Pace Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
75d
Days
Class 3
Risk

K864153 is an FDA 510(k) clearance for the PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Pace Medical (Waltham, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 75 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 Pace Medical devices

Submission Details

510(k) Number K864153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1986
Decision Date January 06, 1987
Days to Decision 75 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 125d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 365
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K864153.
MODEL 366-13 ADAPTAID STEP DOWN ADAPTER
K864326 · Intermedics, Inc. · Jan 1987
MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD
K862051 · Intermedics, Inc. · Jan 1987
MEDTRONIC MODEL 5013
K863536 · Medtronic Vascular · Jan 1987
ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD
K864640 · Cordis Corp. · Jan 1987
MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP
K864738 · Intermedics, Inc. · Jan 1987
MODEL 5866-24 PACEMAKER LEAD ADAPTOR
K864856 · Medtronic Vascular · Jan 1987