Cleared Traditional

FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH (K032884) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032884 · Boston Scientific Epi · Cardiovascular device
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Aug 2004
Decision
325d
Days
Class 2
Risk

K032884 is an FDA 510(k) clearance for the FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH. Classified as Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection (product code NFA), Class II - Special Controls.

Submitted by Boston Scientific Epi (Santa Clara, US). The FDA issued a Cleared decision on August 6, 2004 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Boston Scientific Epi devices

Submission Details

510(k) Number K032884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2003
Decision Date August 06, 2004
Days to Decision 325 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
200d slower than avg
Panel avg: 125d · This submission: 325d
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 21
Devices cleared under the same product code (NFA) and FDA review panel - the closest regulatory comparables to K032884.
INTERCEPTOR PLUS CORONARY FILTER SYSTEMS
K073523 · Medtronic, Inc. · Aug 2008
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
MODIFICATION TO EXPORT ASPIRATION CATHETER
K030201 · Medtronic Vascular · Mar 2003