510(k) · Cleared
Recalled · Class II · 2020Pacific Xtreme Ptca Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Dec 22, 2010 as substantially equivalent to K042537 (Invatec Innovative Technologies, 2004) and 2 other predicates after a 28-day review. Its family tree reaches back 3 generations to 2004. 9 later devices descend from it. It has been recalled once.
- Decided
- Dec 22, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- LIT
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K042537 (2004). 9 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 2 generations backK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
- 1 generation backK083919 Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2009 · Recalled
- This deviceK103464 Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc. · 2010
- Descendant · cites it directly · 6 of its ownK133843 Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · Recalled
- Descendant · 2 generations on · 4 of its ownK151153 Pirouette 018Arravasc Limited · 2015
- Descendant · 3 generations on · 2 of its ownK162316 Pirouette 014Arravasc, Ltd. · 2016
- Descendant · 3 generations on · 2 of its ownK161427 Pirouette 035Arravasc Limited · 2016
- Descendant · 3 generations on · 1 of its ownK173621 Advocate PTA CatheterMerit Medical Systems, Inc. · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · cites it directly6descendants
- K151153Pirouette 018Arravasc Limited · 2015 · 2 generations on4descendants
- K162316Pirouette 014Arravasc, Ltd. · 2016 · 3 generations on2descendants
- K161427Pirouette 035Arravasc Limited · 2016 · 3 generations on2descendants
- K173621Advocate PTA CatheterMerit Medical Systems, Inc. · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042537 | Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −2 | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters | ClearStream Technologies, Ltd. | 2008 | — |
| −1 | K083919 | Amphirion Deep 0.014 Otw Pta Balloon Catheter | Invatec Innovative Technologies, S.R.L. | 2009 | 1 |
| 0 (this device) | K103464 | Pacific Xtreme Ptca Balloon Dilatation Catheter | Medtronic, Inc. | 2010 | — |
| +1 | K133843 | Saber Percutaneous Transluminal Angioplasty Dilatation Catheter | Cordis Corporation | 2014 | 1 |
| +2 | K151153 | Pirouette 018 | Arravasc Limited | 2015 | — |
| +3 | K162316 | Pirouette 014 | Arravasc, Ltd. | 2016 | — |
| +3 | K161427 | Pirouette 035 | Arravasc Limited | 2016 | — |
| +3 | K173621 | Advocate PTA Catheter | Merit Medical Systems, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042537 | Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model SuvxxxxxxxxxSummary page 2…2 Mronic Predicate Devices: Invatec SUBMARINE PLUS PTA Balloon catheter (K042537) Invatec AMPHIRION DEEP OTW PTA Balloon Dilatation Catheter (K0839 19) Invatec ADMIRAL XTREME PTA Balloon Catheter (K100921) De… | 2004 |
| * | K083919 | Amphirion Deep 0.014 Otw Pta Balloon CatheterSummary page 2…2 Mronic Predicate Devices: Invatec SUBMARINE PLUS PTA Balloon catheter (K042537) Invatec AMPHIRION DEEP OTW PTA Balloon Dilatation Catheter (K0839 19) Invatec ADMIRAL XTREME PTA Balloon Catheter (K100921) Device Description: The PACIFIC XTREMETM PTA Balloon Dilatation Cathete… | 2009 |
| * | K100921 | Admiral Xtreme Pta Balloon Dilatation CatheterSummary page 2…Invatec SUBMARINE PLUS PTA Balloon catheter (K042537) Invatec AMPHIRION DEEP OTW PTA Balloon Dilatation Catheter (K0839 19) Invatec ADMIRAL XTREME PTA Balloon Catheter (K100921) Device Description: The PACIFIC XTREMETM PTA Balloon Dilatation Catheter is an over-the-wire Percutaneouls Transluminal Angio… | 2010 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 26, 2020 | Class II | Z-3055-2020 | Under Investigation by firm | Labeling discrepancy for the Rated Burst Pressure (RBP) value. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K133843 (Cordis Corporation, 2014) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K042537.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 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 PACIFIC XTREME PTA Balloon Dilatation Catheter in 150mm, 200mm, 250mm and 300mm balloon length is intended to dilate stenoses in the femoral, popliteal, and infrapopliteal arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103464 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103464: Pacific Xtreme Ptca 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/K103464
Report an extraction error
Are you the manufacturer?
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