Cleared Special

K133208 - INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM

K133208 is the FDA 510(k) clearance for INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code KRD) cleared through the Special 510(k) pathway after a 27-day FDA review.

K133208 · Boston Scientific Corp · Cardiovascular device
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Nov 2013
Decision
27d
Days
Class 2
Risk

K133208 is an FDA 510(k) clearance for the INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM. 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 November 14, 2013 after a review of 27 days - a notably fast clearance cycle.

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

View all Boston Scientific Corp devices

Submission Details

510(k) Number K133208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2013
Decision Date November 14, 2013
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 92
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K133208.
IDC INTERLOCKING DETACHABLE COIL
K141378 · Boston Scientific Corporation · Oct 2014
GEL-BEAD EMBOLIZATION SPHERES
K133237 · Vascular Solutions, Inc. · Apr 2014
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
K133626 · MicroVention, Inc. · Dec 2013
AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
K132083 · MicroVention, Inc. · Oct 2013
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
K132578 · Boston Scientific Corp · Sep 2013
AZUR PUSHABLE 18 & 35 SYSTEM
K130577 · MicroVention, Inc. · Jun 2013