Cleared Special

K010099 - ZYNERGY Z3K BALLOON GUIDED PACING AND M...

K010099 is an FDA 510(k) clearance for ZYNERGY Z3K BALLOON GUIDED PACING AND M..., manufactured by Zcv ,Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Special 510(k) pathway after a 21-day FDA review.

K010099 · Zcv ,Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
21d
Days
Class 2
Risk

K010099 is an FDA 510(k) clearance for the ZYNERGY Z3K 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 February 1, 2001 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zcv ,Inc. devices

FDA 510(k) Submission Details - K010099

510(k) Number K010099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2001
Decision Date February 01, 2001
Days to Decision 21 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 K010099.
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