Cleared Special

K051179 - EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150

K051179 is an FDA 510(k) clearance for EZ PLUS RETRIEVAL SHEATH, 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 30-day FDA review.

K051179 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
30d
Days
Class 2
Risk

K051179 is an FDA 510(k) clearance for the EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150. 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 June 8, 2005 after a review of 30 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.

FDA 510(k) Submission Details - K051179

510(k) Number K051179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2005
Decision Date June 08, 2005
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 K051179.
SPIDERX EMBOLIC PROTECTION DEVICE
K053195 · Ev3, Inc. · Jun 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
TRIACTIV SYSTEM
K042040 · Kensey Nash Corp. · Mar 2005
FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH
K032884 · Boston Scientific Epi · Aug 2004
BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC
K023691 · Boston Scientific Epi · Jun 2003
K051179 · EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
Download PDF FDA Summary Boston Scientific Corp