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)
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.

View all Trans Vascular Incorporated devices

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
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 Peers - ITX Transducer, Ultrasonic, Diagnostic

All 316
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K013363.
TERATECH MODEL 10V5 SMART PROBE
K040840 · Teratech Corp. · Apr 2004
ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
K030064 · Sonosite,Inc. · Jan 2003
ATLANTIS PV IMAGING CATHETER, MODEL 36456
K022860 · Boston Scientific, Target · Nov 2002
SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
K013721 · CIVCO Medical Instruments Co., Inc. · Dec 2001
ULTRASOUND TRANSDUCER COVER
K011265 · Advance Medical Designs, Inc. · Oct 2001
OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
K011314 · Aloka Co., Ltd. · May 2001