Cleared Traditional

K062192 - OSTIAL PRO STENT POSITIONING SYSTEM

K062192 is an FDA 510(k) clearance for OSTIAL PRO STENT POSITIONING SYSTEM, manufactured by Ostial Solutions, LLC. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K062192 · Ostial Solutions, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
297d
Days
Class 2
Risk

K062192 is an FDA 510(k) clearance for the OSTIAL PRO STENT POSITIONING SYSTEM. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Ostial Solutions, LLC (Sunnyvale, US). The FDA issued a Cleared decision on May 24, 2007 after a review of 297 days - an extended review 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: 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 Ostial Solutions, LLC devices

FDA 510(k) Submission Details - K062192

510(k) Number K062192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2006
Decision Date May 24, 2007
Days to Decision 297 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
172d slower than avg
Panel avg: 125d · This submission: 297d
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 635
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K062192.
ASAHI PTCA GUIDE WIRE, X-TREME
K072431 · Asahi Intecc Co., Ltd. · Sep 2007
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
K071029 · Stereotaxis, Inc. · Aug 2007
ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371
K071721 · Asahi Intecc Co., Ltd. · Jul 2007
RUNTHROUGH NS
K063695 · Terumo Medical Corp. · Apr 2007
COOK MICROWIRE WIRE GUIDE
K070410 · Cook, Inc. · Apr 2007
VASCUPUNCTURE PICC GUIDEWIRE
K070150 · Neometrics, Inc. · Feb 2007