Cleared Traditional

ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3 (K002687) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K002687 · Zynergy Cardiovascular, Inc. · Cardiovascular device
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Nov 2000
Decision
72d
Days
Class 2
Risk

K002687 is an FDA 510(k) clearance for the ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Zynergy Cardiovascular, Inc. (Edison, US). The FDA issued a Cleared decision on November 9, 2000 after a review of 72 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zynergy Cardiovascular, Inc. devices

Submission Details

510(k) Number K002687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2000
Decision Date November 09, 2000
Days to Decision 72 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 125d · This submission: 72d
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 47
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K002687.
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
K012458 · Medtronic Vascular · Aug 2001
MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE
K012459 · Medtronic Vascular · Aug 2001
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
K012460 · Medtronic Vascular · Aug 2001
MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD
K973360 · Medtronic Vascular · May 1998
TEMPORARY CARDIAC PACING WIRE
K980503 · Ethicon, Inc. · Apr 1998
INTRODUCER SHEATH AND DILATOR
K971165 · Boston Scientific Corp · Jul 1997