Cleared Special

K033542 - EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE

K033542 is an FDA 510(k) clearance for EASY PASS HYDROPHILIC COATED VASCULAR G..., manufactured by Galt Medical Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 25-day FDA review.

K033542 · Galt Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
25d
Days
Class 2
Risk

K033542 is an FDA 510(k) clearance for the EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on December 5, 2003 after a review of 25 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 Galt Medical Corp. devices

FDA 510(k) Submission Details - K033542

510(k) Number K033542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2003
Decision Date December 05, 2003
Days to Decision 25 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
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 682
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K033542.
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K032031 · Intra Luminal Therapeutics, Inc. · Jan 2004
HYDROPHILIC GUIDEWIRE
K033758 · Lake Region Mfg., Inc. · Dec 2003
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K033708 · Intra Luminal Therapeutics, Inc. · Dec 2003
SELECTIVA SB GUIDEWIRE
K033321 · Neometrics, Inc. · Nov 2003
VASCUPUNCTURE PICC GUIDEWIRE
K031652 · Neometrics, Inc. · Sep 2003
ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
K032615 · Asahi Intecc Co., Ltd. · Sep 2003