Cleared Special

K073563 - MODIFICATION TO PROXIS SYSTEM (FDA 510(k) Clearance)

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

K073563 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
43d
Days
Class 2
Risk

K073563 is an FDA 510(k) clearance for the MODIFICATION TO PROXIS SYSTEM. Classified as Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection (product code NFA), Class II - Special Controls.

Submitted by St Jude Medical (Maple Grove, US). The FDA issued a Cleared decision on January 31, 2008 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 St Jude Medical devices

Submission Details

510(k) Number K073563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2007
Decision Date January 31, 2008
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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.