Cleared Traditional

K991060 - ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER

K991060 is an FDA 510(k) clearance for ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, manufactured by Zcv ,Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 373-day FDA review.

K991060 · Zcv ,Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
373d
Days
Class 2
Risk

K991060 is an FDA 510(k) clearance for the ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Zcv ,Inc. (Edison, US). The FDA issued a Cleared decision on April 6, 2000 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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. Elevated predicate reliance profile. 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 - K991060

510(k) Number K991060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1999
Decision Date April 06, 2000
Days to Decision 373 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
248d slower than avg
Panel avg: 125d · This submission: 373d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRF Device Classification - Class 2, Special Controls

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 99
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K991060.
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ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
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K971265 · C.R. Bard, Inc. · Oct 1997
ELECTRODE RECORDING CATHETER
K954651 · Boston Scientific Corp · Oct 1996