510(k) · Cleared
Recalled · Class II · 2014Atlantis Pvimaging Catheter, Model H749364560
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Mar 11, 2008 as substantially equivalent to K050684 (Boston Scientific Corp, 2005) after a 39-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 11, 2008
- Review
- 39 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050684 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK050684 Atlantis PVBoston Scientific Corp · 2005
- This deviceK080272 Atlantis Pvimaging Catheter, Model H749364560Boston Scientific Corp · 2008
- Descendant · cites it directly · 0 of its ownK200733 Opticross 35 15 MHz Peripheral Imaging CatheterBoston Scientific Corporation · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K200733Opticross 35 15 MHz Peripheral Imaging CatheterBoston Scientific Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050684 | Atlantis PV | Boston Scientific Corp | 2005 | — |
| 0 (this device) | K080272 | Atlantis Pvimaging Catheter, Model H749364560 | Boston Scientific Corp | 2008 | — |
| +1 | K200733 | Opticross 35 15 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K050684 | Atlantis PVSummary page 1…AtlantisTM PV Imaging Catheter is substantially equivalent to the following predicate device: AtlantisTM PV Imaging Boston Scientific Corporation K050684 Catheter Traditional 510(k) Atlantis TMPV Imaging Catheter January 31, 2008… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200733 | Opticross 35 15 MHz Peripheral Imaging Catheter | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 6, 2014 | Class II | Z-0900-2014 | Equipment maintenance | Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter. |
| Oct 9, 2008 | Not classified | Z-0837-2009 | Labeling mix-ups | Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K200733 (Boston Scientific Corporation, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The AtlantisTM PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080272: Atlantis Pvimaging Catheter, Model H749364560.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080272
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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