Cleared Traditional

K023691 - BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC

K023691 is an FDA 510(k) clearance for BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC, manufactured by Boston Scientific Epi. The device is a Class 2 Cardiovascular device with product code NFA cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K023691 · Boston Scientific Epi · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
215d
Days
Class 2
Risk

K023691 is an FDA 510(k) clearance for the BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC. 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 June 4, 2003 after a review of 215 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 Boston Scientific Epi devices

FDA 510(k) Submission Details - K023691

510(k) Number K023691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2002
Decision Date June 04, 2003
Days to Decision 215 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
90d slower than avg
Panel avg: 125d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFA Device Classification - Class 2, Special Controls

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 16
Devices cleared under the same product code (NFA) and FDA review panel - the closest regulatory comparables to K023691.
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
K052280 · Boston Scientific Corp · Nov 2005
EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
K051179 · Boston Scientific Corp · Jun 2005
TRIACTIV SYSTEM
K042040 · Kensey Nash Corp. · Mar 2005
MODIFICATION TO EXPORT ASPIRATION CATHETER
K030201 · Medtronic Vascular · Mar 2003
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K023878 · Medtronic Vascular · Jan 2003
EXPORT ASPIRATION CATHETER
K023303 · Medtronic Vascular · Oct 2002