Cleared Special

K031920 - CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001

K031920 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 Special 510(k) pathway after a 30-day FDA review.

K031920 · Trans Vascular Incorporated · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
30d
Days
Class 2
Risk

K031920 is an FDA 510(k) clearance for the CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001. 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 July 23, 2003 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031920

510(k) Number K031920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2003
Decision Date July 23, 2003
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 414
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K031920 · CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001
Download PDF FDA Summary Trans Vascular Incorp…