Cleared Traditional

K013363 - CROSSPOINT TRANSACCESS CATHETER

K013363 is an FDA 510(k) clearance for CROSSPOINT TRANSACCESS CATHETER, manufactured by Trans Vascular Incorporated. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K013363 · Trans Vascular Incorporated · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
174d
Days
Class 2
Risk

K013363 is an FDA 510(k) clearance for the CROSSPOINT TRANSACCESS CATHETER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Trans Vascular Incorporated (Menlo Park, US). The FDA issued a Cleared decision on April 2, 2002 after a review of 174 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K013363

510(k) Number K013363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2001
Decision Date April 02, 2002
Days to Decision 174 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 107d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 Radiology devices follow this clearance model.

Regulatory Consultant

Tuv Product Service, Inc.
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 414
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K013363.
ATLANTIS PV IMAGING CATHETER, MODEL 36456
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MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
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TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS
K014182 · Tetrad Corp. · Jan 2002
SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
K013721 · CIVCO Medical Instruments Co., Inc. · Dec 2001
K013363 · CROSSPOINT TRANSACCESS CATHETER
Download PDF FDA Summary Trans Vascular Incorp…