510(k) · Cleared
ClearedPython Catheter/Over-the-Wire Latis Graft Cleaning Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corporation · DXE Catheter, Embolectomy
Cleared on Sep 7, 2021 as substantially equivalent to K970762 (Applied Medical Resources, 1997) and 1 other predicate after a 410-day review. Its family tree reaches back 2 generations to 1991. 2 of the 5 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 7, 2021
- Review
- 410 days
- Class
- Class II
- Product code
- DXE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K910372 (1991). 4 ancestors in all. No later device cites it as a predicate yet. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK910372 Intimax Thrombectomy CatheterApplied Vascular Devices, Inc. · 1991 · Recalled
- 1 generation backK973465 Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · Recalled (Class I)
- This deviceK202049 Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterApplied Medical Resources Corporation · 2021
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910372 | Intimax Thrombectomy Catheter | Applied Vascular Devices, Inc. | 1991 | 1 |
| −1 | K973465 | Latis Graft Cleaning Catheter | Applied Medical Resources | 1998 | Class I |
| 0 (this device) | K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter | Applied Medical Resources Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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 DXE device
- #1 K240078 Fogarty Thru-Lumen Embolectomy Catheterscore 7.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K970762 | Dual Lumen Embolectomy CatheterSummary page 5…KRA – Catheter, Continuous Flush (21 CFR 870.1210) Device Class: Class II Predicate Python Catheter Devices: 510(k)#: K970762 Product Code: DXE Over-the-Wire Latis Graft Cleaning Catheter 51… | 1997 |
| * | K973465 | Latis Graft Cleaning CatheterSummary page 5…Devices: 510(k)#: K970762 Product Code: DXE Over-the-Wire Latis Graft Cleaning Catheter 510(k)#: K973465 Produce Code: DXE Model Numbers: A4E01 CE0340DR A4GW6 A4E02… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 23.5 years on median.
- 3 of the 4 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K970762.
How does its category compare?
All DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DXE
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DXE
173in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXE
1in 2023
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DXE
306in 2025
MAUDE reports naming product code DXE, 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 | 0 | — | 3 | 167 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 0 | — | 5 | 124 |
| 2010 | 2 | — | 1 | 136 |
| 2011 | 0 | — | 1 | 164 |
| 2012 | 0 | — | 0 | 200 |
| 2013 | 0 | — | 0 | 150 |
| 2014 | 0 | — | 0 | 192 |
| 2015 | 1 | — | 13 | 266 |
| 2016 | 0 | — | 0 | 796 |
| 2017 | 2 | — | 0 | 770 |
| 2018 | 0 | — | 0 | 615 |
| 2019 | 0 | — | 0 | 594 |
| 2020 | 1 | — | 0 | 547 |
| 2021 | 1 | — | 4 (4) | 333 |
| 2022 | 1 | — | 3 | 463 |
| 2023 | 0 | — | 1 | 436 |
| 2024 | 5 | 173 | 0 | 377 |
| 2025 | 0 | — | 0 | 306 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
Python catheters are indicated for removal of thromboemboli from the peripheral arterial system, and for occlusion and infusion of fluids into a vessel.
The Over-the-Wire Latis Graft Cleaning Catheter is indicated for the removal ofthromboemboli from vascular grafts, and for occlusion and infusion of fluids into a graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202049: Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202049
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026