510(k) · Cleared
ClearedCrosspoint Transaccess Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trans Vascular Incorporated · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Apr 2, 2002 as substantially equivalent to K001577 (Lumend, Inc., 2001) after a 174-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it.
- Decided
- Apr 2, 2002
- Review
- 174 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001577 (2001). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001577 Outback CatheterLumend, Inc. · 2001 · Recalled
- This deviceK013363 Crosspoint Transaccess CatheterTrans Vascular Incorporated · 2002
- Descendant · cites it directly · 4 of its ownK031920 Crosspoint Transaccess Catheter, Model TA-XP-001Trans Vascular Incorporated · 2003 · Recalled
- Descendant · cites it directly · 3 of its ownK072155 Pioneer CatheterMedtronic, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK081804 Pioneer Plus CatheterMedtronic, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 1 of its ownK101777 Pioneer Plus Catheter, Model Plus 120Medtronic Vascular · 2010 · Recalled
- Descendant · 4 generations on · 0 of its ownK162418 Pioneer Plus CatheterPhilips Volcano · 2016
Most influential descendants
Showing 5 of 5 · See all- K031920Crosspoint Transaccess Catheter, Model TA-XP-001Trans Vascular Incorporated · 2003 · cites it directly4descendants
- K072155Pioneer CatheterMedtronic, Inc. · 2007 · cites it directly3descendants
- K081804Pioneer Plus CatheterMedtronic, Inc. · 2008 · 2 generations on2descendants
- K101777Pioneer Plus Catheter, Model Plus 120Medtronic Vascular · 2010 · 3 generations on1descendant
- K162418Pioneer Plus CatheterPhilips Volcano · 2016 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001577 | Outback Catheter | Lumend, Inc. | 2001 | 1 |
| 0 (this device) | K013363 | Crosspoint Transaccess Catheter | Trans Vascular Incorporated | 2002 | — |
| +1 | K031920 | Crosspoint Transaccess Catheter, Model TA-XP-001 | Trans Vascular Incorporated | 2003 | 1 |
| +1 | K072155 | Pioneer Catheter | Medtronic, Inc. | 2007 | — |
| +2 | K081804 | Pioneer Plus Catheter | Medtronic, Inc. | 2008 | 2 |
| +3 | K101777 | Pioneer Plus Catheter, Model Plus 120 | Medtronic Vascular | 2010 | 1 |
| +4 | K162418 | Pioneer Plus Catheter | Philips Volcano | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001577 | Outback CatheterSummary page 1…ent Device: The subject device (CrossPoint TransAccess Catheter) is substantially equlvalent in intended use and/or method of operation to the Perclose Outback Catheter (K001577) and Endosonics' devices, Visions 2.9F Ultrasonic Imaging Catheter and Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter.… | 2001 |
| * | — | Visions 2.9F Ultrasonic Imaging Catheter Named without a submission number | |
| * | — | Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013363: Crosspoint Transaccess Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013363
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026