Cleared Special

Inqwire Diagnostic Guide Wire (K170700) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K170700 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
30d
Days
Class 2
Risk

K170700 is an FDA 510(k) clearance for the Inqwire Diagnostic Guide Wire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Galway, IE). The FDA issued a Cleared decision on April 6, 2017 after a review of 30 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 Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K170700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2017
Decision Date April 06, 2017
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 343
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K170700.
Approach CTO Microwire Guide
K171897 · Cook Incorporated · Aug 2017
True Form Reshapable Guide Wire
K170532 · Merit Medical Systems, Inc. · Jul 2017
Merit Hydrophilic Guide Wire
K170933 · Merit Medical Systems, Inc. · Jun 2017
ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension
K163426 · Asahi Intecc Co., Ltd. · Apr 2017
Fathom-16 Steerable Guidewires
K170636 · Boston Scientific Corporation · Mar 2017
Inqwire Diagnostic Guide Wire
K163575 · Merit Medical Systems, Inc. · Mar 2017