Cleared Traditional

K033858 - TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE

K033858 is an FDA 510(k) clearance for TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE, manufactured by European Custom Manufacturing BV. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K033858 · European Custom Manufacturing BV · Cardiovascular device
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Jul 2004
Decision
214d
Days
Class 2
Risk

K033858 is an FDA 510(k) clearance for the TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by European Custom Manufacturing BV (Gemert, NL). The FDA issued a Cleared decision on July 12, 2004 after a review of 214 days - an extended review 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: 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 European Custom Manufacturing BV devices

FDA 510(k) Submission Details - K033858

510(k) Number K033858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2003
Decision Date July 12, 2004
Days to Decision 214 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 125d · This submission: 214d
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 90
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K033858.
TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)
K072770 · Oscor, Inc. · Jan 2008
MODEL 6416 TEMPORARY PACING LEAD SYSTEM
K042190 · Medtronic Vascular · Sep 2004
DETECT SURGICAL PACING AND MAPPING TOOL
K040812 · Medtronic Vascular · Sep 2004
DISPOSABLE TEMPORARY PACING WIRE
K023174 · River Medical, Inc. · Jun 2003
STEELEX ELECTRODE SET
K030556 · Aesculap, Inc. · Apr 2003
MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
K012452 · Medtronic Vascular · Aug 2001