Cleared Special

K140673 - INSERTION TOOL

K140673 is the FDA 510(k) clearance for INSERTION TOOL by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Special 510(k) pathway after a 29-day FDA review.

K140673 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
29d
Days
Class 2
Risk

K140673 is an FDA 510(k) clearance for the INSERTION TOOL. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on April 16, 2014 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 K140673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2014
Decision Date April 16, 2014
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 427
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K140673.
ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE
K141339 · Asahi Intecc Co., Ltd. · Oct 2014
MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
K140608 · Merit Medical Systems, Inc. · Sep 2014
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE
K140695 · Medtronic, Inc. · Jun 2014
ASAHI GAIA FIRST, SECOND, THIRD
K133865 · Asahi Intecc Co., Ltd. · Mar 2014
INQWIRE DIAGNOSTIC GUIDE WIRE
K133230 · Merit Medical Systems, Inc. · Dec 2013
MERIT HYDROPHILIC GUIDE WIRE
K131710 · Merit Medical Systems, Inc. · Jul 2013