510(k) · Cleared
ClearedSemi Compliant (SC) 35 Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Mar 23, 2000 after a 171-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Mar 23, 2000
- Review
- 171 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK993303 Semi Compliant (SC) 35 Balloon Dilatation CatheterBoston Scientific Corp · 2000
- Descendant · cites it directly · 2 of its ownK110122 Mustang Balloon Dilataion CathetersBoston Scientific · 2011
- Descendant · 2 generations on · 0 of its ownK141597 Mustang Balloon Dialation CatheterBoston Scientific Corporation · 2014
- Descendant · 2 generations on · 0 of its ownK112701 Charger Balloon Dilatation CatheterBoston Scientific · 2011
Most influential descendants
Showing 3 of 3 · See all- K110122Mustang Balloon Dilataion CathetersBoston Scientific · 2011 · cites it directly2descendants
- K141597Mustang Balloon Dialation CatheterBoston Scientific Corporation · 2014 · 2 generations on0descendants
- K112701Charger Balloon Dilatation CatheterBoston Scientific · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993303 | Semi Compliant (SC) 35 Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| +1 | K110122 | Mustang Balloon Dilataion Catheters | Boston Scientific | 2011 | — |
| +2 | K141597 | Mustang Balloon Dialation Catheter | Boston Scientific Corporation | 2014 | — |
| +2 | K112701 | Charger Balloon Dilatation Catheter | Boston Scientific | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2014 | 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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · 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 |
|---|---|---|---|
| * | — | Ultra-thin Diamond Dilatation Catheter Named without a submission number | |
| * | — | Courier ST Balloon Dilatation Catheter Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110122 | Mustang Balloon Dilataion Catheters | 2011 | 2 |
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, K110122 (Boston Scientific, 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
The Semi Compliant 35 Balloon Dilatation Catheter is indicated for stent deployment/optimization of the J&J Paimaz Biliary Stent and for the treatment of biliary strictures.
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/K993303 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993303: Semi Compliant (SC) 35 Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993303
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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