Cleared Special

K170636 - Fathom-16 Steerable Guidewires

K170636 is an FDA 510(k) clearance for Fathom-16 Steerable Guidewires, manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 20-day FDA review.

K170636 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
20d
Days
Class 2
Risk

K170636 is an FDA 510(k) clearance for the Fathom-16 Steerable Guidewires. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on March 22, 2017 after a review of 20 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.

FDA 510(k) Submission Details - K170636

510(k) Number K170636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2017
Decision Date March 22, 2017
Days to Decision 20 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
105d faster than avg
Panel avg: 125d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

DQX Device Classification - Class 2, Special Controls

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 768
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K170636.
Merit Hydrophilic Guide Wire
K170933 · Merit Medical Systems, Inc. · Jun 2017
Inqwire Diagnostic Guide Wire
K170700 · Merit Medical Systems, Inc. · Apr 2017
ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension
K163426 · Asahi Intecc Co., Ltd. · Apr 2017
Inqwire Diagnostic Guide Wire
K163575 · Merit Medical Systems, Inc. · Mar 2017
Radifocus Glidewire Advantage Track
K163004 · Ashitaka Factory of Terumo Coporation · Jan 2017
ASAHI PTCA Guide Wire ASAHI SUOH 03
K162842 · Asahi Intecc Co., Ltd. · Jan 2017
K170636 · Fathom-16 Steerable Guidewires
Download PDF FDA Summary Boston Scientific Cor…