510(k) · Cleared

Cleared

Boston Scientific Talon Balloon Dilatation Catheter

K060960510(k) TraditionalCleared Apr 12, 20065-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 Corporation · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Apr 12, 2006 as substantially equivalent to K000798 (Boston Scientific Corp, 2000) after a 5-day review. Its family tree reaches back 1 generation to 2000.

Decided: Apr 12, 2006
Review: 5 days
Class: Class II
Product code: LIT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000798 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK000798 Talon Balloon Dilation CatheterBoston Scientific Corp · 2000
This deviceK060960 Boston Scientific Talon Balloon Dilatation CatheterBoston Scientific Corporation · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000798	Talon Balloon Dilation Catheter	Boston Scientific Corp	2000	—
0 (this device)	K060960	Boston Scientific Talon Balloon Dilatation Catheter	Boston Scientific Corporation	2006	—

FIG. 1 — Lineage of K060960, 2000–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K000798	Talon Balloon Dilation Catheter Summary page 1 …e Balloon Dilatation Catheter Product Code LIT Classification of Class II,21 CFR Part 870.1250 Device Predicate Device Talon Balloon K000798 June 8, 2000 Dilatation Catheter Device The Talon Balloon Dilatation Catheter is an o…	Boston Scientific Corp	2000	—

Also cleared against K000798: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
1 other device also cites its predicate K000798.

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	—

What is it indicated for?

The Boston Scientific Talon Balloon Dilatation Catheter is indicated for

Percutaneous Transluminal Angioplasty (PTA) of the iliac, femoral, ilio-femoral,

popliteal, 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/K060960 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060960: Boston Scientific Talon 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/K060960

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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