# K013363: Crosspoint Transaccess Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Trans Vascular Incorporated
- Decided: Apr 2, 2002 after 174 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001577 (2001). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001577: Outback Catheter, Lumend, Inc. (2001) Summary page 1.
- (no number) Visions 2.9F Ultrasonic Imaging Catheter: named in the summary without a submission number
- (no number) Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter: named in the summary without a submission number

## Most influential descendants
- K031920: Crosspoint Transaccess Catheter, Model TA-XP-001 (2003), 4 descendants of its own
- K072155: Pioneer Catheter (2007), 3 descendants of its own
- K081804: Pioneer Plus Catheter (2008), 2 descendants of its own
- K101777: Pioneer Plus Catheter, Model Plus 120 (2010), 1 descendant of its own
- K162418: Pioneer Plus Catheter (2016), 0 descendants of its own

## Indications for use
The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the area of interest. The CrossPoint TransAccess Catheter is not indicated for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K013363
Methodology: https://510kreport.com/methodology