Cleared Traditional

K073523 - INTERCEPTOR PLUS CORONARY FILTER SYSTEMS

K073523 is the FDA 510(k) clearance for INTERCEPTOR PLUS CORONARY FILTER SYSTEMS by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code NFA) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K073523 · Medtronic, Inc. · Cardiovascular device
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Aug 2008
Decision
231d
Days
Class 2
Risk

K073523 is an FDA 510(k) clearance for the INTERCEPTOR PLUS CORONARY FILTER SYSTEMS. Classified as Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection (product code NFA), Class II - Special Controls.

Submitted by Medtronic, Inc. (Danvers, US). The FDA issued a Cleared decision on August 1, 2008 after a review of 231 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Medtronic, Inc. devices

Submission Details

510(k) Number K073523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2007
Decision Date August 01, 2008
Days to Decision 231 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 125d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

All 9
Devices cleared under the same product code (NFA) and FDA review panel - the closest regulatory comparables to K073523.
MODIFICATION TO PROXIS SYSTEM
K073563 · St Jude Medical · Jan 2008
PROXIS SYSTEM, MODEL EPS101
K060651 · St Jude Medical · Sep 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
K061332 · Boston Scientific Corp · Aug 2006
FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300
K051984 · Boston Scientific Corp · Apr 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
K052280 · Boston Scientific Corp · Nov 2005
EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
K051179 · Boston Scientific Corp · Jun 2005