Cleared Special

K142259 - Direxion Torqueable Microcatheter

K142259 is the FDA 510(k) clearance for Direxion Torqueable Microcatheter by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Special 510(k) pathway after a 27-day FDA review.

K142259 · Boston Scientific Corp · Cardiovascular device
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Sep 2014
Decision
27d
Days
Class 2
Risk

K142259 is an FDA 510(k) clearance for the Direxion Torqueable Microcatheter. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on September 10, 2014 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 K142259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2014
Decision Date September 10, 2014
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 KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 75
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K142259.
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CXI SUPPORT CATHETER
K122796 · Cook, Inc. · Oct 2012