510(k) · Cleared
ClearedBlue Max - 20 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 Nov 19, 1997 after a 147-day review. The FDA summary names its predicate without a number. 1 of the 32 devices in its family, counting itself, has a Class I recall. 31 later devices descend from it.
- Decided
- Nov 19, 1997
- Review
- 147 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 1 citing it directly. 1 of the 32 devices in this family, counting this one, has a Class I recall.
- This deviceK972357 Blue Max - 20 Balloon Dilatation CatheterBoston Scientific Corp · 1997
- Descendant · cites it directly · 30 of its ownK041630 Orbital Atherectomy System for Treatment of a-V Shunt StenosisCardiovascular Systems Incorporated · 2005
- Descendant · 2 generations on · 28 of its ownK071427 Diamondback 360 Degree Orbital Atherectomy System for Treatment of…Cardiovascular Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 28 of its ownK071350 Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- Descendant · 3 generations on · 26 of its ownK072748 Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- Descendant · 3 generations on · 25 of its ownK081944 Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc. · 2008
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133399 Diamondback 360 Peripheral Orbital Atherectomy…4 generations on · 2013
Most influential descendants
Showing 5 of 31 · See all- K041630Orbital Atherectomy System for Treatment of a-V Shunt StenosisCardiovascular Systems Incorporated · 2005 · cites it directly30descendants
- K071427Diamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt StenosisCardiovascular Systems, Inc. · 2007 · 2 generations on28descendants
- K071350Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007 · 2 generations on28descendants
- K072748Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007 · 3 generations on26descendants
- K081944Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc. · 2008 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972357 | Blue Max - 20 Balloon Dilatation Catheter | Boston Scientific Corp | 1997 | — |
| +1 | K041630 | Orbital Atherectomy System for Treatment of a-V Shunt Stenosis | Cardiovascular Systems Incorporated | 2005 | — |
| +2 | K071427 | Diamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt… | Cardiovascular Systems, Inc. | 2007 | 2 |
| +2 | K071350 | Diamondback 360 Degree Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| +3 | K072748 | Modification to: Diamondback 360 Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| +3 | K081944 | Modification to Diamondback 360 Degree Orbital Atherectomy System | Cardio Systems, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 1 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | — | Blue Max Balloon Dilatation Catheter Named without a submission number | |
| * | — | Ultra-thin Diamond Balloon Dilatation Catheter Named without a submission number |
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041630 | Orbital Atherectomy System for Treatment of a-V Shunt Stenosis | 2005 | 30 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133399Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K041630 (Cardiovascular Systems Incorporated, 2005) has gone furthest, with 30 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?
Blue Max 20 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972357 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972357: Blue Max - 20 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/K972357
Report an extraction error
Are you the manufacturer?
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