Cleared Special

K041531 - ASAHI PTCA GUIDE WIRE CONFIANZA PRO

K041531 is an FDA 510(k) clearance for ASAHI PTCA GUIDE WIRE CONFIANZA PRO, manufactured by Asahi Intecc Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 56-day FDA review.

K041531 · Asahi Intecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
56d
Days
Class 2
Risk

K041531 is an FDA 510(k) clearance for the ASAHI PTCA GUIDE WIRE CONFIANZA PRO. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Asahi Intecc Co., Ltd. (Newport Beach, US). The FDA issued a Cleared decision on August 3, 2004 after a review of 56 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 Asahi Intecc Co., Ltd. devices

FDA 510(k) Submission Details - K041531

510(k) Number K041531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2004
Decision Date August 03, 2004
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K041531.
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
K042338 · Lake Region Mfg., Inc. · Sep 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K041973 · Intra Luminal Therapeutics, Inc. · Aug 2004
FINISHING WIRE SUPPORTRAK
K041762 · Guidant Corporation · Aug 2004
PTCA STEERABLE HYDROPHILIC GUIDEWIRE
K041624 · Lake Region Mfg., Inc. · Jul 2004
LAKE REGION HYDROPHILIC GUIDEWIRE
K040825 · Lake Region Mfg., Inc. · May 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
K040867 · Boston Scientific Corp · Apr 2004