Cleared Traditional

K864507 - V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540

K864507 is an FDA 510(k) clearance for V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MO..., manufactured by Spectramed, Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K864507 · Spectramed, Inc. · Cardiovascular device
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Mar 1987
Decision
112d
Days
Class 2
Risk

K864507 is an FDA 510(k) clearance for the V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Spectramed, Inc. (Findley, US). The FDA issued a Cleared decision on March 6, 1987 after a review of 112 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: Standard predicate-based submission. Standard predicate reliance. 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 Spectramed, Inc. devices

FDA 510(k) Submission Details - K864507

510(k) Number K864507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1986
Decision Date March 06, 1987
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDF Device Classification - Class 2, Special Controls

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - LDF Electrode, Pacemaker, Temporary

All 93
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K864507.
TEMPORARY PACEMAKER ELECTRODE
K872972 · Oscor Medical Corp. · Dec 1987
DEKNATEL TEMPORARY CARDIAC PACING WIRE
K873728 · Deknatel, Inc. · Nov 1987
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K862970 · Medtronic Vascular · Sep 1987
TB SERIES BIPOLAR PACING LEADS
K861403 · Oscor Medical Corp. · Jun 1986
FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT
K855139 · Davis & Geck, Inc. · Feb 1986
MEDTRONIC MODEL 6405
K853818 · Medtronic Vascular · Oct 1985