Cleared Traditional

K141378 - IDC INTERLOCKING DETACHABLE COIL

K141378 is an FDA 510(k) clearance for IDC INTERLOCKING DETACHABLE COIL, manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K141378 · Boston Scientific Corporation · Cardiovascular device
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Oct 2014
Decision
134d
Days
Class 2
Risk

K141378 is an FDA 510(k) clearance for the IDC INTERLOCKING DETACHABLE COIL. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on October 8, 2014 after a review of 134 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 Corporation devices

FDA 510(k) Submission Details - K141378

510(k) Number K141378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2014
Decision Date October 08, 2014
Days to Decision 134 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
9d slower than avg
Panel avg: 125d · This submission: 134d
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 120
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K141378.
ENDOLUMINAL OCCLUSION SYSTEM (EOS)
K133924 · Artventive Medical Group, Inc. · Dec 2014
MEDUSA VASCULAR PLUG,
K140796 · Endoshape, Inc. · Dec 2014
Gel-Block 10X embolization pledgets
K143038 · Vascular Solutions, Inc. · Nov 2014
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES
K141209 · Celonova Biosciences, Inc. · Aug 2014
REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
K141313 · Reverse Medical Corporation · Jun 2014
GEL-BEAD EMBOLIZATION SPHERES
K133237 · Vascular Solutions, Inc. · Apr 2014