Cleared Special

K061332 - FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)

K061332 is an FDA 510(k) clearance for FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM..., manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code NFA cleared through the Special 510(k) pathway after a 91-day FDA review.

K061332 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
91d
Days
Class 2
Risk

K061332 is an FDA 510(k) clearance for the FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM). Classified as Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection (product code NFA), Class II - Special Controls.

Submitted by Boston Scientific Corp (Mountain View, US). The FDA issued a Cleared decision on August 11, 2006 after a review of 91 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K061332

510(k) Number K061332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2006
Decision Date August 11, 2006
Days to Decision 91 days
Submission Type Special
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
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

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 21
Devices cleared under the same product code (NFA) and FDA review panel - the closest regulatory comparables to K061332.
TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02
K062870 · Kensey Nash Corp. · Oct 2006
PROXIS SYSTEM, MODEL EPS101
K060651 · St Jude Medical · Sep 2006
PROXIS SYSTEM
K052523 · Velocimed, Inc. · Sep 2006
SPIDERX EMBOLIC PROTECTION DEVICE
K062201 · Ev3, Inc. · Aug 2006
TRIACTIV FX EMBOLIC PROTECTION SYSTEM
K061772 · Kensey Nash Corp. · Jul 2006
SPIDERX EMBOLIC PROTECTION DEVICE
K053195 · Ev3, Inc. · Jun 2006
K061332 · FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
Download PDF FDA Summary Boston Scientific Corp