Cleared Traditional

K102912 - INTERLOCK FIBERED IDC OCCLUSION SYSTEM

K102912 is the FDA 510(k) clearance for INTERLOCK FIBERED IDC OCCLUSION SYSTEM by Boston Scientific. It is a Class 2 Cardiovascular device (product code KRD) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K102912 · Boston Scientific · Cardiovascular device
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Mar 2011
Decision
153d
Days
Class 2
Risk

K102912 is an FDA 510(k) clearance for the INTERLOCK FIBERED IDC OCCLUSION SYSTEM. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on March 3, 2011 after a review of 153 days - an extended review cycle.

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 devices

Submission Details

510(k) Number K102912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2010
Decision Date March 03, 2011
Days to Decision 153 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
28d slower than avg
Panel avg: 125d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 95
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K102912.
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K113651 · Boston Scientific Corporation · Jan 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K112103 · Boston Scientific Corp · Aug 2011
AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
K111307 · MicroVention, Inc. · Jun 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K110295 · Boston Scientific Corp · Mar 2011
COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL
K102714 · Boston Scientific Corp · Feb 2011
MICROPLEX COIL SYSTEM- COSMOS
K102365 · MicroVention, Inc. · Nov 2010