Cleared Special

GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM (K024071) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K024071 · Guidant Corporation, Cardiac Surgery · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2003
Decision
66d
Days
Class 2
Risk

K024071 is an FDA 510(k) clearance for the GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM. Classified as Electrode, Pacing And Cardioversion, Temporary, Epicardial (product code NHW), Class II - Special Controls.

Submitted by Guidant Corporation, Cardiac Surgery (Santa Clara, US). The FDA issued a Cleared decision on February 14, 2003 after a review of 66 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 Guidant Corporation, Cardiac Surgery devices

Submission Details

510(k) Number K024071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2002
Decision Date February 14, 2003
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NHW Electrode, Pacing And Cardioversion, Temporary, Epicardial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
Definition The System Is Indicated For Use In Postoperative Cardiac Surgery Patients Who Require Temporary Atrial Or Ventricular Pacing/sensing And/or Atrial Cardioversion. Epicardial Defibrillation Electrodes Can Be Implanted Up To 7 Days.
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.