Cleared Special

K163701 - Direxion and Direxion HI-FLO Torqueable Microcatheters

K163701 is an FDA 510(k) clearance for Direxion and Direxion HI-FLO Torqueable..., manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Special 510(k) pathway after a 138-day FDA review.

K163701 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
138d
Days
Class 2
Risk

K163701 is an FDA 510(k) clearance for the Direxion and Direxion HI-FLO Torqueable Microcatheters. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on May 16, 2017 after a review of 138 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K163701

510(k) Number K163701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2016
Decision Date May 16, 2017
Days to Decision 138 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
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Modification to existing cleared device.

KRA Device Classification - Class 2, Special Controls

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 176
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K163701.
Microcatheter and guide-wire system
K171665 · Suzhou Hengrui Disheng Medical Co., Ltd. · Jan 2018
CXI TriForce Peripheral Crossing Set
K170931 · Cook Incorporated · Nov 2017
Maestro Microcatheter
K172081 · Merit Medical Systems, Inc. · Aug 2017
FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm
K161967 · Callisyn Biomedical, Inc. · Jan 2017
VAMP Venous/Arterial Blood Management Protection System
K161962 · Edwards Lifesciences, LLC · Nov 2016
CXI Support Catheter
K160884 · Cook Incorporated · Nov 2016
K163701 · Direxion and Direxion HI-FLO Torqueable Microcatheters
Download PDF FDA Summary Boston Scientific Cor…