510(k) Report

PMA · Approved

Approved

Usci Dilatation Catheter

P790017PMAApproved Mar 24, 1980283-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

Medtronic, Ireland · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

Approved on Mar 24, 1980 through premarket approval, which rests on the device’s own clinical evidence after a 283-day review. 67 later devices descend from it.

Decided
Mar 24, 1980
Review
283 days
Class
Class II
Product code
LOX
Recalls
None

67 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 2016: 4 descendants cleared2012: 1 descendant cleared2011: 4 descendants cleared2013: 2 descendants cleared2014: 3 descendants cleared2003: 2 descendants cleared2026: 4 descendants cleared2010: 2 descendants cleared2015: 2 descendants cleared2004: 2 descendants cleared2008: 2 descendants cleared2006: 5 descendants cleared2018: 6 descendants cleared2017: 3 descendants cleared2023: 3 descendants cleared2021: 5 descendants cleared2022: 2 descendants cleared2024: 3 descendants cleared2020: 2 descendants cleared2019: 3 descendants cleared2025: 4 descendants cleared2005: 1 descendant cleared2007: 1 descendant cleared2009: 1 descendant cleared19801990200020102020
  1. This deviceP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
  2. Descendant · cites it directly · 29 of its ownK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
  3. Descendant · 2 generations on · 17 of its ownK042194 Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004
  4. Descendant · 3 generations on · 14 of its ownK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
  5. Descendant · cites it directly · 13 of its ownK103095 Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw BalloonMedtronic, Ireland · 2010
  6. Descendant · 4 generations on · 13 of its ownK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

2003: 22004: 22005: 12006: 52007: 12008: 22009: 12010: 22011: 42012: 12013: 22014: 32015: 22016: 42017: 32018: 62019: 32020: 22021: 52022: 22023: 32024: 32025: 42026: 4
2003high 6 (2018) · low 1 (2005)2026

Most influential descendants

Showing 5 of 67 · See all
  • K031211Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003 · cites it directly29descendants
  • K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004 · 2 generations on17descendants
  • K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006 · 3 generations on14descendants
  • K103095Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw BalloonMedtronic, Ireland · 2010 · cites it directly13descendants
  • K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc. · 2008 · 4 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P790017Usci Dilatation CatheterMedtronic, Ireland1980—
+1K031211Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular2003—
+2K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular2004—
+3K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland2006—
+1K103095Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw BalloonMedtronic, Ireland2010—
+4K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide…Medtronic, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200420
200510
200650
200710
200820
200910
201020
201140
201210
201320
201430
201520
201640
201730
201860
201930
202020
202150
202220
202330
202430
202540
202640
FIG. 1 — Lineage of P790017, 1980–2026Source: 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 PMA database (decision fields and supplements), 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

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (67)

See all 67

13 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031211Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular200329
K103095Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw BalloonMedtronic, Ireland201013
K103808Sapphire NCOrbusneich Medical, Inc.201111
K112735Tamarin Blue Ptca RX Dilatation CatheterNatec Medical, Ltd.20125
K103657SapphireOrbusneich Medical, Inc.20115
K160985Pantera ProBiotronik, Inc.20163
K143480Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic, Inc.20153
K133852Apollo Balloon Dilatation CatheterBrosmed Medical20142
K141090NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic, Inc.20142
K131169Mozec - RX Ptca Balloon Dilatation CatheterMeril Life Sciences Private Limited20132

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, K031211 (Medtronic Vascular, 2003) has gone furthest, with 29 descendants of its own.

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.

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—

More from Medtronic, Ireland

250 FDA decisions under this applicant name. See the company

  • K251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland · 2026
  • K252390Telescope Guide Extension CatheterMedtronic, Ireland · 2025
  • K250787Liberant Thrombectomy SystemMedtronic, Ireland · 2025
  • P030009/S101Integrity Coronary Stent SystemsMedtronic, Ireland · 2022
  • P030009/S107Integrity Rapid Exchange Coronary Stent System, Integrity Over The Wire Coronary Stent SystemMedtronic, Ireland · 2022

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/P790017 · printed Nov 6, 2026

Cite this page

510(k) Report. “P790017: Usci Dilatation Catheter.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P790017

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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