Cleared Traditional

K090554 - ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE

K090554 is the FDA 510(k) clearance for ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K090554 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
122d
Days
Class 2
Risk

K090554 is an FDA 510(k) clearance for the ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on July 2, 2009 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K090554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2009
Decision Date July 02, 2009
Days to Decision 122 days
Submission Type Traditional
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
3d faster than avg
Panel avg: 125d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 486
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K090554.
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
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
K091385 · Cook, Inc. · Aug 2009
MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
K082873 · Medtronic Vascular · Feb 2009
ASAHI SUOH PTCA GUIDE WIRE
K083904 · Asahi Intecc Co., Ltd. · Jan 2009
ASAHI GUIDE WIRE EXTENSION, MODEL AG149000
K083145 · Asahi Intecc Co., Ltd. · Jan 2009