Cleared Traditional

K002603 - ZYNERGY BALLOONPACE BALLOON GUIDED PACI...

K002603 is an FDA 510(k) clearance for ZYNERGY BALLOONPACE BALLOON GUIDED PACI..., manufactured by Zcv ,Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K002603 · Zcv ,Inc. · Cardiovascular device
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Jan 2001
Decision
139d
Days
Class 2
Risk

K002603 is an FDA 510(k) clearance for the ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Zcv ,Inc. (Edison, US). The FDA issued a Cleared decision on January 8, 2001 after a review of 139 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 Zcv ,Inc. devices

FDA 510(k) Submission Details - K002603

510(k) Number K002603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2000
Decision Date January 08, 2001
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
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 82
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K002603.
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
SAFPACE SYSTEM
K955829 · B.Braun Medical, Inc. · Nov 1997