Cleared Traditional

K934787 - SILICORE SEMI-FLOATER

K934787 is an FDA 510(k) clearance for SILICORE SEMI-FLOATER, manufactured by Electro-Catheter Corp.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 507-day FDA review.

K934787 · Electro-Catheter Corp. · Cardiovascular device
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Feb 1995
Decision
507d
Days
Class 2
Risk

K934787 is an FDA 510(k) clearance for the SILICORE SEMI-FLOATER. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Electro-Catheter Corp. (Rahway, US). The FDA issued a Cleared decision on February 24, 1995 after a review of 507 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. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

FDA 510(k) Submission Details - K934787

510(k) Number K934787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1993
Decision Date February 24, 1995
Days to Decision 507 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
382d slower than avg
Panel avg: 125d · This submission: 507d
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 106
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K934787.
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491
K944956 · The Heart Valve Div. Medtronic Cardiovascular Surg · Jul 1995
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K944957 · Medtronic Blood Systems, Inc. · Jul 1995
UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492
K944966 · Medtronic Blood Systems, Inc. · Jul 1995
BIPOLAR BALLOON PACING CATHETER BY J-LLOYD
K930069 · J-Lloyd Medical, Inc. · Jan 1994
ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD
K924388 · Angemed, Inc. · Oct 1993
ANGEMED 5000 LEAD ADAPTER
K924390 · Angemed, Inc. · Aug 1993
K934787 · SILICORE SEMI-FLOATER
Download PDF Electro-Catheter Corp.