510(k) · Cleared
ClearedCourier ST Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Dec 11, 1997 after a 141-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.
- Decided
- Dec 11, 1997
- Review
- 141 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 1 citing it directly.
- This deviceK972744 Courier ST Balloon Dilatation CatheterBoston Scientific Corp · 1997
- Descendant · cites it directly · 20 of its ownK011889 Ultra -Thin SDS Balloon Dilatation CatheterBoston Scientific Corp · 2001
- Descendant · 2 generations on · 14 of its ownK082339 Enabler-P Support CatheterEndocross, Ltd. · 2008
- Descendant · 3 generations on · 12 of its ownK083833 Enabler-P Catheter, 1000 Part Number:1160Endocross, Ltd. · 2009
- Descendant · 3 generations on · 9 of its ownK092174 Enabler-P Catheter System, Model 3000Endocross, Ltd. · 2009
- Descendant · 4 generations on · 8 of its ownK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K011889Ultra -Thin SDS Balloon Dilatation CatheterBoston Scientific Corp · 2001 · cites it directly20descendants
- K082339Enabler-P Support CatheterEndocross, Ltd. · 2008 · 2 generations on14descendants
- K083833Enabler-P Catheter, 1000 Part Number:1160Endocross, Ltd. · 2009 · 3 generations on12descendants
- K092174Enabler-P Catheter System, Model 3000Endocross, Ltd. · 2009 · 3 generations on9descendants
- K121763Multicross Support CatheterRoxwood Medical, Inc. · 2012 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972744 | Courier ST Balloon Dilatation Catheter | Boston Scientific Corp | 1997 | — |
| +1 | K011889 | Ultra -Thin SDS Balloon Dilatation Catheter | Boston Scientific Corp | 2001 | — |
| +2 | K082339 | Enabler-P Support Catheter | Endocross, Ltd. | 2008 | — |
| +3 | K083833 | Enabler-P Catheter, 1000 Part Number:1160 | Endocross, Ltd. | 2009 | — |
| +3 | K092174 | Enabler-P Catheter System, Model 3000 | Endocross, Ltd. | 2009 | — |
| +4 | K121763 | Multicross Support Catheter | Roxwood Medical, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | — | BSC - Courier Balloon Dilatation Catheter Named without a submission number |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011889 | Ultra -Thin SDS Balloon Dilatation Catheter | 2001 | 20 |
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, K011889 (Boston Scientific Corp, 2001) has gone furthest, with 20 descendants of its own.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Courier ST Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the Iliac, Femoral and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Courier ST Catheters are not indicated for use in coronary arteries or the neurovasculature.
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/K972744 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972744: Courier ST Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972744
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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