510(k) · Cleared

Cleared

Blue Max Balloon Dilatation Catheter, Maxforce Balloon Catheter, XXL Balloon Dilatation Cathater, Symmetry Balloon Dila

K000570510(k) SpecialCleared Apr 13, 200051-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corp · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Apr 13, 2000 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Apr 13, 2000
Review: 51 days
Class: Class II
Product code: LIT
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK000570 Blue Max Balloon Dilatation Catheter, Maxforce Balloon Catheter, XXL…Boston Scientific Corp · 2000
Descendant · cites it directly · 0 of its ownK071309 Blue Max Balloon Dilatation CatheterBoston Scientific Corp · 2007 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K071309Blue Max Balloon Dilatation CatheterBoston Scientific Corp · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000570	Blue Max Balloon Dilatation Catheter, Maxforce Balloon Catheter, XXL Balloon…	Boston Scientific Corp	2000	—
+1	K071309	Blue Max Balloon Dilatation Catheter	Boston Scientific Corp	2007	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K000570, 2000–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071309	Blue Max Balloon Dilatation Catheter	Boston Scientific Corp	2007	0

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, K071309 (Boston Scientific Corp, 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LIT devices

LIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LIT

3in 2025

2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007high 205 (2026) · low 29 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LIT

1in 2025

2007high 3 (2014) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LIT

2,073in 2025

2007high 2,492 (2021) · low 513 (2008)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	—

https://510kreport.com/device/K000570 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000570: Blue Max Balloon Dilatation Catheter, Maxforce Balloon Catheter, XXL Balloon Dilatation Cathater, Symmetry Balloon Dila.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000570

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026