Cleared Traditional

K864507 - V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MO...

K864507 is the FDA 510(k) clearance for V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MO... by Spectramed, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 78
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K864507.
DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE
K875059 · Daig Corp. · Feb 1988
DEKNATEL TEMPORARY CARDIAC PACING WIRE
K873728 · Deknatel, Inc. · Nov 1987
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K862970 · Medtronic Vascular · Sep 1987
FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT
K855139 · Davis & Geck, Inc. · Feb 1986
MEDTRONIC MODEL 6405
K853818 · Medtronic Vascular · Oct 1985
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
K851913 · Cordis Corp. · Sep 1985