Cleared Traditional

K070212 - CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM)

K070212 is an FDA 510(k) clearance for CITOP10 GUIDEWIRE, manufactured by Ovalum , Ltd.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K070212 · Ovalum , Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2007
Decision
263d
Days
Class 2
Risk

K070212 is an FDA 510(k) clearance for the CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITO.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Ovalum , Ltd. (Rehovot, IL). The FDA issued a Cleared decision on October 12, 2007 after a review of 263 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 Ovalum , Ltd. devices

FDA 510(k) Submission Details - K070212

510(k) Number K070212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2007
Decision Date October 12, 2007
Days to Decision 263 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
138d slower than avg
Panel avg: 125d · This submission: 263d
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 629
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K070212.
ASAHI PTCA GUIDE WIRE
K070945 · Asahi Intecc Co., Ltd. · Jan 2008
MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE
K072552 · Merit Medical Systems, Inc. · Dec 2007
ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J
K072705 · Asahi Intecc Co., Ltd. · Oct 2007
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