Cleared Traditional

K102714 - COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL

K102714 is an FDA 510(k) clearance for COMPLEX HELICAL 18, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K102714 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
144d
Days
Class 2
Risk

K102714 is an FDA 510(k) clearance for the COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM .... Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on February 11, 2011 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - 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 Corp devices

FDA 510(k) Submission Details - K102714

510(k) Number K102714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2010
Decision Date February 11, 2011
Days to Decision 144 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
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRD Device Classification - Class 2, Special Controls

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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 - KRD Device, Vascular, For Promoting Embolization

All 111
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K102714.
AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
K111307 · MicroVention, Inc. · Jun 2011
INTERLOCK FIBERED IDC OCCLUSION SYSTEM
K102912 · Boston Scientific · Mar 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K110295 · Boston Scientific Corp · Mar 2011
MICROPLEX COIL SYSTEM- COSMOS
K102365 · MicroVention, Inc. · Nov 2010
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610
K093002 · MicroVention, Inc. · Oct 2009
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM
K091882 · MicroVention, Inc. · Jul 2009