Cleared Traditional

K050756 - SKIPPER AND SKIPPER RACE GUIDEWIRE

K050756 is an FDA 510(k) clearance for SKIPPER AND SKIPPER RACE GUIDEWIRE, manufactured by Invatec Innovative Technologies, S.R.L.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K050756 · Invatec Innovative Technologies, S.R.L. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
43d
Days
Class 2
Risk

K050756 is an FDA 510(k) clearance for the SKIPPER AND SKIPPER RACE GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Invatec Innovative Technologies, S.R.L. (Plymouth, US). The FDA issued a Cleared decision on May 5, 2005 after a review of 43 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 Invatec Innovative Technologies, S.R.L. devices

FDA 510(k) Submission Details - K050756

510(k) Number K050756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2005
Decision Date May 05, 2005
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
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 627
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K050756.
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM
K051374 · Stereotaxis, Inc. · Jun 2005
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
GALEO FOCUS GUIDE WIRE
K042373 · Biotronik, Inc. · Mar 2005
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
K043398 · Neometrics, Inc. · Mar 2005
MODIFICATION TO ENDOVASCULAR GUIDE WIRE
K043457 · Stereotaxis, Inc. · Feb 2005