510(k) Report

510(k) · Cleared

Cleared

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters

K162625510(k) TraditionalCleared Jun 12, 2017265-day reviewClass II21 CFR 870.5100

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

B. Braun Interventional Systems, Inc. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

Cleared on Jun 12, 2017 as substantially equivalent to K113220 (Boston Scientific Corporation, 2012) and 2 other predicates after a 265-day review. Its family tree reaches back 4 generations to 1986.

Decided
Jun 12, 2017
Review
265 days
Class
Class II
Product code
LOX
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to P860019 (1986). No later device cites it as a predicate yet.

P860019 · Scimed Ptca Dilatation Catheter · Scimed Life Systems, Inc. · 1986 · recalledK113220 · Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire) · Boston Scientific Corporation · 2012 · recalledK121196 · Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire) · Boston Scientific Corp · 2012 · recalledK130391 · Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter, Emerge Over-the-Wire Ptca Dilat · Boston Scientific Corp · 2013 · recalled1985199019952000200520102015
K130391 · Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter, Emerge Over-the-Wire Ptca Dilat · Boston Scientific Corp · 2013 · recalledK121196 · Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire) · Boston Scientific Corp · 2012 · recalledK113220 · Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire) · Boston Scientific Corporation · 2012 · recalledP860019 · Scimed Ptca Dilatation Catheter · Scimed Life Systems, Inc. · 1986 · recalled0
  1. Root · 4 generations backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
  2. 3 generations backK113220 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corporation · 2012 · Recalled
  3. 2 generations backK121196 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corp · 2012 · Recalled
  4. 1 generation backK130391 Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca…Boston Scientific Corp · 2013 · Recalled
  5. This deviceK162625 SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA)…B. Braun Interventional Systems, Inc. · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4P860019Scimed Ptca Dilatation CatheterScimed Life Systems, Inc.19865
−3K113220Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter…Boston Scientific Corporation20121
−2K121196Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter…Boston Scientific Corp20121
−1K130391Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation…Boston Scientific Corp20131
0 (this device)K162625SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon…B. Braun Interventional Systems, Inc.2017—
FIG. 1 — Lineage of K162625, 1986–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 LOX? 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 LOX device

  1. #1 K254022 FLASH Flex™ Aorto-Ostial Angioplasty Systemscore 12.3 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K113220Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)
Summary page 4
…ode: LOX; Panel: Cardiovascular Predicate Boston Scientific Corporation, Emerge™ Monorail® PTCA Device(s) Dilatation Catheter (K113220, K121196, & K130391) Device Description The SeQuent® Neo PTCA-Catheter is a balloon-tipped, rapid exchange catheter. The distal…
Boston Scientific Corporation20121
*K121196Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)
Summary page 4
…Panel: Cardiovascular Predicate Boston Scientific Corporation, Emerge™ Monorail® PTCA Device(s) Dilatation Catheter (K113220, K121196, & K130391) Device Description The SeQuent® Neo PTCA-Catheter is a balloon-tipped, rapid exchange catheter. The distal shaft (2…
Boston Scientific Corp20121
*K130391Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter…
Summary page 4
…Cardiovascular Predicate Boston Scientific Corporation, Emerge™ Monorail® PTCA Device(s) Dilatation Catheter (K113220, K121196, & K130391) Device Description The SeQuent® Neo PTCA-Catheter is a balloon-tipped, rapid exchange catheter. The distal shaft (25 cm) consi…
Boston Scientific Corp20131

Also cleared against K113220: 5 other devices →

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?

  • The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
  • 4 of the 4 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K113220.

How does its category compare?

All LOX devices

LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · LOX

4in 2024

2007: 192008: 222009: 282010: 322011: 92012: 102013: 62014: 62015: 42016: 92017: 62018: 72019: 12020: 12021: 62022: 52023: 42024: 42026 (partial year): 6
2007high 32 (2010) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOX

241in 2024

2011: 103 days median2012: 120 days median2013: 123 days median2014: 166 days median2015: 119 days median2016: 116 days median2017: 113 days median2018: 80 days median2021: 167 days median2022: 121 days median2023: 138 days median2024: 241 days median2026 (partial year): 156 days median
2007high 241 (2024) · low 80 (2018)2026

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

Recalls per year · LOX

4in 2019

2007: 12008: 802019: 4
2007high 80 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LOX

1,890in 2025

2007: 1,0532008: 1,0632009: 1,3532010: 1,3922011: 2,0902012: 2,0922013: 2,4362014: 2,3162015: 2,0602016: 2,5782017: 2,7532018: 2,2252019: 2,1022020: 1,9742021: 1,7382022: 1,8162023: 1,7202024: 1,8042025: 1,890
2007high 2,753 (2017) · low 1,053 (2007)2025

MAUDE reports naming product code LOX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200719—11,053
200822—801,063
200928—01,353
201032—01,392
2011910302,090
20121012002,092
2013612302,436
2014616602,316
2015411902,060
2016911602,578
2017611302,753
201878002,225
20191—42,102
20201—01,974
2021616701,738
2022512101,816
2023413801,720
2024424101,804
20250—01,890
202661560—

What is it indicated for?

The SeQuent® Neo PTCA Dilatation Catheters are indicated for the balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon sizes 2.00-4.00mm are also indicated for post-delivery expansion of balloon expandable stents.

Indications for use as stated in the FDA summary.

Also cleared against K113220

5 other devices cite the same predicate.

  • K162253Trapper Exchange DeviceCreganna Medical Aslo Business AS Cregganna Tactx Medical · 2017
  • K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation · 20161 recall
  • K141236NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation Catheter (Over-the-Wire)Boston Scientific Corporation · 20141 recall
  • K130391Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter, Emerge…Boston Scientific Corp · 20131 recall
  • K121196Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)Boston Scientific Corp · 20121 recall

More from B. Braun Interventional Systems, Inc.

3 FDA decisions under this applicant name. See the company

  • K152765Venatech Convertible Vena Cava Filter SystemB. Braun Interventional Systems, Inc. · 2016
  • K130576Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. · 20132 recalls

Recent decisions in LOX

The LOX category page

  • K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic Ireland · 2026
  • K261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic Ireland · 2026
  • K252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd. · 2026
  • K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc. · 2026
  • K252295RyureiTerumo Corporation · 2026

https://510kreport.com/device/K162625 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162625: SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162625

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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