510(k) · Cleared

Cleared

MS Classique Balloon Catheter W/Hydropass Coating

K953647510(k) TraditionalCleared May 16, 1997651-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

Meadox Medicals, Div. Boston Scientific Corp. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on May 16, 1997 as substantially equivalent to K942293 (Meadox Medicals, Div. Boston Scientific Corp., 1994) and 1 other predicate after a 651-day review. Its family tree reaches back 1 generation to 1994.

Decided: May 16, 1997
Review: 651 days
Class: Class II
Product code: LIT
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K943298 (1994). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK943298 MS Classique Balloon CatheterMeadox Medicals, Div. Boston Scientific Corp. · 1994
This deviceK953647 MS Classique Balloon Catheter W/Hydropass CoatingMeadox Medicals, Div. Boston Scientific Corp. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943298	MS Classique Balloon Catheter	Meadox Medicals, Div. Boston Scientific Corp.	1994	—
0 (this device)	K953647	MS Classique Balloon Catheter W/Hydropass Coating	Meadox Medicals, Div. Boston Scientific Corp.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

FIG. 1 — Lineage of K953647, 1994–1997Source: 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? (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	Applicant	Decided	Recalls
*	K942293	MS Classique Balloon Catheter Summary page 1 …devices for this premarket notification submission: Ty et o P erel fhagaSnipL (Lo elote oy b TP I ST o p}s-‘»*r" F O B I RN (< betebatsbiti it st ittt bttt datatetely K942293 \|MS CLASSIQUE™ Balloon Dilatation Catheter 10/18/94 K943298 \| MS CLASSIQUE™ Balloon Dilatation Catheter 09/08/94 HYDROPASS™ is…	Meadox Medicals, Div. Boston Scientific Corp.	1994	—
*	K943298	MS Classique Balloon Catheter Summary page 1 …P erel fhagaSnipL (Lo elote oy b TP I ST o p}s-‘»*r" F O B I RN (< betebatsbiti it st ittt bttt datatetely K942293 \|MS CLASSIQUE™ Balloon Dilatation Catheter 10/18/94 K943298 \| MS CLASSIQUE™ Balloon Dilatation Catheter 09/08/94 HYDROPASS™ is a trademark of Meadox Medii The MS CLASSIQUE™ Balloon Dilata…	Meadox Medicals, Div. Boston Scientific Corp.	1994	—

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?

None of the 2 ancestors has a recall.

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/K953647 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953647: MS Classique Balloon Catheter W/Hydropass Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953647

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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