510(k) · Cleared
ClearedPta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NuMED, Inc. · DXF Catheter, Septostomy
Cleared on Jul 12, 2001 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Jul 12, 2001
- Review
- 52 days
- Class
- Class II
- Product code
- DXF
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK011557 Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersNuMED, Inc. · 2001
- Descendant · cites it directly · 11 of its ownK073166 Endowave Infusion SystemEkos Corp. · 2008
- Descendant · 2 generations on · 10 of its ownK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · Recalled
- Descendant · 3 generations on · 9 of its ownK111705 Ekosonic Endovascular SystemEkos Corporation · 2011 · Recalled
- Descendant · 4 generations on · 8 of its ownK183290 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular…Thrombolex, Inc. · 2019
- Descendant · 5 generations on · 2 of its ownK192864 UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K073166Endowave Infusion SystemEkos Corp. · 2008 · cites it directly11descendants
- K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · 2 generations on10descendants
- K111705Ekosonic Endovascular SystemEkos Corporation · 2011 · 3 generations on9descendants
- K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc. · 2019 · 4 generations on8descendants
- K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011557 | Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters | NuMED, Inc. | 2001 | — |
| +1 | K073166 | Endowave Infusion System | Ekos Corp. | 2008 | — |
| +2 | K081467 | Ekosonic Endovascular System with Rapid Pulse Modulation | Ekos Corp. | 2008 | 5 |
| +3 | K111705 | Ekosonic Endovascular System | Ekos Corporation | 2011 | 5 |
| +4 | K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter… | Thrombolex, Inc. | 2019 | — |
| +5 | K192864 | UNI*FUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXF? 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 DXF device
- #1 K242076 VersaCross™ RF Wirescore 14.9 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 142 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?
- Of its descendants, K073166 (Ekos Corp., 2008) has gone furthest, with 11 descendants of its own.
How does its category compare?
All DXF devicesDXF Catheter, Septostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXF
83in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXF
3in 2020
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DXF
682in 2025
MAUDE reports naming product code DXF, 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 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 0 | — | 1 | 13 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 36 |
| 2019 | 1 | — | 0 | 24 |
| 2020 | 0 | — | 3 (3) | 55 |
| 2021 | 1 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 70 |
| 2023 | 1 | — | 0 | 286 |
| 2024 | 4 | 83 | 0 | 368 |
| 2025 | 2 | — | 0 | 682 |
| 2026 | 3 | 30 | 0 | — |
https://510kreport.com/device/K011557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011557: Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011557
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026