Cleared Traditional

K051062 - VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST

Also marketed or referenced as:
VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO

K051062 is an FDA 510(k) clearance for VP WIRE GW140ST (.014 165CM, manufactured by Flowcardia, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K051062 · Flowcardia, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
80d
Days
Class 2
Risk

K051062 is an FDA 510(k) clearance for the VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Flowcardia, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 15, 2005 after a review of 80 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Flowcardia, Inc. devices

FDA 510(k) Submission Details - K051062

510(k) Number K051062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2005
Decision Date July 15, 2005
Days to Decision 80 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 625
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K051062.
ASAHI PTCA GUIDE WIRE
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CARDIODRIVE CATHETER ADVANCEMENT SYSTEM
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SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]
K050915 · Intra Luminal Therapeutics, Inc. · Jun 2005
CANALIZER HYDROPHILIC GUIDE WIRE
K050873 · Medical Device Technologies, Inc. · May 2005