510(k) · Cleared
Recalled · 2010Blue Max 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 Jul 13, 2007 as substantially equivalent to K000570 (Boston Scientific Corp, 2000) after a 65-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.
- Decided
- Jul 13, 2007
- Review
- 65 days
- Class
- Class II
- Product code
- LIT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000570 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000570 Blue Max Balloon Dilatation Catheter, Maxforce Balloon Catheter, XXL…Boston Scientific Corp · 2000
- This deviceK071309 Blue Max Balloon Dilatation CatheterBoston Scientific Corp · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000570 | Blue Max Balloon Dilatation Catheter, Maxforce Balloon Catheter, XXL Balloon… | Boston Scientific Corp | 2000 | — |
| 0 (this device) | K071309 | Blue Max Balloon Dilatation Catheter | Boston Scientific Corp | 2007 | — |
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 |
|---|---|---|---|
| * | K000570 | Blue Max Balloon Dilatation Catheter, Maxforce Balloon Catheter, XXL Balloon Dilatation…Summary page 1…e Balloon Dilatation Catheter Product Code LIT Classification of Class 11, 21 CFR Part 870.1250 Device Predicate Device Blue Max Tm Balloon K000570 April 13, 2000 Dilatation Catheter Device The Blue MaxTM Balloon Dilatation Catheter,… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2010 | Not classified | Z-1211-2010 | Packaging | Boston Scientific Corporation is conducting a Medical Device Recall Removal of specific lots/batches of the Blue Max and Ultrathin Diamond Balloon Dilatation Catheters. Boston Scientific has determined that, the sterile barrier in the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071309: Blue Max 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/K071309
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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