Cleared Special

K091385 - APPROACH HYDRO ST WIRE GUIDE

K091385 is the FDA 510(k) clearance for APPROACH HYDRO ST WIRE GUIDE by Cook, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Special 510(k) pathway after a 89-day FDA review.

K091385 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
89d
Days
Class 2
Risk

K091385 is an FDA 510(k) clearance for the APPROACH HYDRO ST WIRE GUIDE, MODEL HMW. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on August 7, 2009 after a review of 89 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 Cook, Inc. devices

Submission Details

510(k) Number K091385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2009
Decision Date August 07, 2009
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
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 500
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K091385.
TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
K093397 · MicroVention, Inc. · Dec 2009
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
K091582 · Medtronic Vascular · Dec 2009
MERIT LAUREATE HYDROPHILIC GUIDE WIRE
K092303 · Merit Medical Systems, Inc. · Oct 2009
ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
K090554 · Boston Scientific Corp · Jul 2009
THE MEDCOMP .010 VASCULAR GUIDEWIRES
K081775 · Medcomp · Mar 2009
MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
K082873 · Medtronic Vascular · Feb 2009