510(k) · Cleared
ClearedWillow/Elm Pta Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creagh Medical, Ltd. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Dec 10, 2010 as substantially equivalent to K050073 (Invatec Innovative Technologies, S.R.L., 2005) and 4 other predicates after an 88-day review. Its family tree reaches back 3 generations to 2004. 6 later devices descend from it.
- Decided
- Dec 10, 2010
- Review
- 88 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K042537 (2004). 8 ancestors in all, the oldest K014212 (2002). 6 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 2 generations backK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
- 1 generation backK083919 Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2009 · Recalled
- This deviceK102645 Willow/Elm Pta Balloon Dilatation CatheterCreagh Medical, Ltd. · 2010
- Descendant · cites it directly · 2 of its ownK171251 014 Hydrophilic Coated PTA Balloon Dilatation CatheterCreagh Medical · 2017
- Descendant · 2 generations on · 1 of its ownK200700 Surmodics Sublime Radial Access 014 RX PTA (Percutaneous…Creagh Medical, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK230191 Arise™ UHP Dilatation CatheterCreagh Medical, Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK211044 Sublime Radial Access 018 RX Dilatation CatheterCreagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, · 2021
- Descendant · cites it directly · 0 of its ownK143561 ELM PTA Balloon Dilatation CatheterO'Connell Regulatory Consultants, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171251014 Hydrophilic Coated PTA Balloon Dilatation CatheterCreagh Medical · 2017 · cites it directly2descendants
- K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty)…Creagh Medical, Ltd. · 2020 · 2 generations on1descendant
- K230191Arise™ UHP Dilatation CatheterCreagh Medical, Ltd. · 2023 · cites it directly0descendants
- K211044Sublime Radial Access 018 RX Dilatation CatheterCreagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, · 2021 · 3 generations on0descendants
- K143561ELM PTA Balloon Dilatation CatheterO'Connell Regulatory Consultants, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042537 | Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −2 | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters | ClearStream Technologies, Ltd. | 2008 | — |
| −1 | K083919 | Amphirion Deep 0.014 Otw Pta Balloon Catheter | Invatec Innovative Technologies, S.R.L. | 2009 | 1 |
| 0 (this device) | K102645 | Willow/Elm Pta Balloon Dilatation Catheter | Creagh Medical, Ltd. | 2010 | — |
| +1 | K171251 | 014 Hydrophilic Coated PTA Balloon Dilatation Catheter | Creagh Medical | 2017 | — |
| +2 | K200700 | Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal… | Creagh Medical, Ltd. | 2020 | — |
| +1 | K230191 | Arise™ UHP Dilatation Catheter | Creagh Medical, Ltd. | 2023 | — |
| +3 | K211044 | Sublime Radial Access 018 RX Dilatation Catheter | Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, | 2021 | — |
| +1 | K143561 | ELM PTA Balloon Dilatation Catheter | O'Connell Regulatory Consultants, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 LIT? 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 LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K050073 | Modification to Amphirion Deep 0.014 Otw Pta Balloon CatheterSummary page 1…AMPHIRION DEEP 0.0 14'OTW PTA Balloon Dilatation Catheter 510(k) Clearance Number: K050073,1K052791,1K042624,1<083919 ELM PTA Balloon Dilatation Catheter predicate Device Name:… | 2005 |
| * | K052791 | Modification to: Amphirion Deep 0.014 Otw Pta Balloon CatheterSummary page 1…AMPHIRION DEEP 0.0 14'OTW PTA Balloon Dilatation Catheter 510(k) Clearance Number: K050073,1K052791,1K042624,1<083919 ELM PTA Balloon Dilatation Catheter predicate Device Name: Vacc… | 2005 |
| * | K042624 | Amphirion Deep 0.014 Otw Pta Balloon CatheterSummary page 1…AMPHIRION DEEP 0.0 14'OTW PTA Balloon Dilatation Catheter 510(k) Clearance Number: K050073,1K052791,1K042624,1<083919 ELM PTA Balloon Dilatation Catheter predicate Device Name: VaccessT PTA… | 2005 |
| * | K083919 | Amphirion Deep 0.014 Otw Pta Balloon CatheterSummary page 1…N DEEP 0.0 14'OTW PTA Balloon Dilatation Catheter 510(k) Clearance Number: K050073,1K052791,1K042624,1<083919 ELM PTA Balloon Dilatation Catheter predicate Device Name: VaccessT PTA Balloon D… | 2009 |
| * | K073472 | Vaccess Pta Balloon Dilatation CatheterSummary page 1…on Dilatation Catheter predicate Device Name: VaccessT PTA Balloon Dilatation Catheter 510(k) Clearance Number: K073472 4. Device Description Both the WILLOW and ELM are co-axial PTA Balloon Dilatation Catheters with a distal… | 2008 |
What descends from it? (6)
4 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?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K171251 (Creagh Medical, 2017) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K050073.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, 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 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
What is it indicated for?
The WILLOW PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The ELM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102645: Willow/Elm Pta Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102645
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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