510(k) · Cleared
ClearedArrow Gpscath Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hotspur Technologies,Inc Subsidiary of Teleflex ME · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jul 2, 2014 as substantially equivalent to K111295 (Boston Scientific Corporation, 2011) after a 141-day review. Its family tree reaches back 7 generations to 2000. 3 later devices descend from it.
- Decided
- Jul 2, 2014
- Review
- 141 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001134 (2000). 9 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 6 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 5 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 4 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 3 generations backK080982 Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation…Boston Scientific Corp · 2008
- 2 generations backK093636 Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation…Boston Scientific Corp · 2009
- 1 generation backK111295 .014 Monorail and Otw Pta Balloon Dilatation CathetersBoston Scientific Corporation · 2011 · Recalled
- This deviceK140351 Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies,Inc Subsidiary of Teleflex ME · 2014
- Descendant · cites it directly · 1 of its ownK142300 Arrow GPSCath Balloon Dialation Catheter (150 cm)Hotspur Technologies, Inc., · 2014
- Descendant · cites it directly · 0 of its ownK191275 All’InCath 035M PTA Balloon Dilatation CatheterNexstep Medical · 2020
- Descendant · cites it directly · 0 of its ownK143093 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)Hotspur Technologies, Inc., · 2015
Most influential descendants
Showing 3 of 3 · See all- K142300Arrow GPSCath Balloon Dialation Catheter (150 cm)Hotspur Technologies, Inc., · 2014 · cites it directly1descendant
- K191275All’InCath 035M PTA Balloon Dilatation CatheterNexstep Medical · 2020 · cites it directly0descendants
- K1430930.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)Hotspur Technologies, Inc., · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −6 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −5 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −4 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −3 | K080982 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters | Boston Scientific Corp | 2008 | — |
| −2 | K093636 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model… | Boston Scientific Corp | 2009 | — |
| −1 | K111295 | .014 Monorail and Otw Pta Balloon Dilatation Catheters | Boston Scientific Corporation | 2011 | 3 |
| 0 (this device) | K140351 | Arrow Gpscath Balloon Dilatation Catheter | Hotspur Technologies,Inc Subsidiary of Teleflex ME | 2014 | — |
| +1 | K142300 | Arrow GPSCath Balloon Dialation Catheter (150 cm) | Hotspur Technologies, Inc., | 2014 | — |
| +1 | K191275 | All’InCath 035M PTA Balloon Dilatation Catheter | Nexstep Medical | 2020 | — |
| +1 | K143093 | 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) | Hotspur Technologies, Inc., | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K111295 | .014 Monorail and Otw Pta Balloon Dilatation CathetersSummary page 1…11 Product Code: LIT C. Predicate Device Name(s): .014 Monorail and OTW PTA Balloon Dilatation Catheters, K1 11295 (Boston Scientific) *5-2 ===… | 2011 |
What descends from it? (3)
3 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 14 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K142300 (Hotspur Technologies, Inc.,, 2014) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K111295.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Arrow GPSCathTh Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, papliteal. infra-popliteal 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/K140351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140351: Arrow Gpscath 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/K140351
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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