510(k) · Cleared
Recalled · 2009Contour Emboli Pva and Fastracker-325 Infusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
Cleared on Sep 23, 2003 as substantially equivalent to K871047 (Interventional Therapeutics Corp., 1987) and 4 other predicates after a 180-day review. Its family tree reaches back 4 generations to 1996. 18 later devices descend from it. It has been recalled once.
- Decided
- Sep 23, 2003
- Review
- 180 days
- Class
- Class II
- Product code
- NAJ
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 4 generations to K961923 (1996). 7 ancestors in all, the oldest K871047 (1987). 18 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 3 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 2 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 1 generation backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- This deviceK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003
- Descendant · cites it directly · 10 of its ownK034068 Contour SE MicrospheresBoston Scientific Corp · 2004
- Descendant · 2 generations on · 6 of its ownK073417 Embozene MicrospheresCelonova Biosciences, Inc. · 2008
- Descendant · 3 generations on · 4 of its ownK132675 Embozene MicrospheresCelonova Biosciences, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK033913 ProgreatTerumo Medical Corp. · 2004
- Descendant · cites it directly · 2 of its ownK133447 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K034068Contour SE MicrospheresBoston Scientific Corp · 2004 · cites it directly10descendants
- K073417Embozene MicrospheresCelonova Biosciences, Inc. · 2008 · 2 generations on6descendants
- K132675Embozene MicrospheresCelonova Biosciences, Inc. · 2013 · 3 generations on4descendants
- K033913ProgreatTerumo Medical Corp. · 2004 · cites it directly3descendants
- K133447Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) MicrospheresCelonova Biosciences, Inc. · 2014 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −3 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −2 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −1 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| 0 (this device) | K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | Boston Scientific Corp | 2003 | — |
| +1 | K034068 | Contour SE Microspheres | Boston Scientific Corp | 2004 | — |
| +2 | K073417 | Embozene Microspheres | Celonova Biosciences, Inc. | 2008 | — |
| +3 | K132675 | Embozene Microspheres | Celonova Biosciences, Inc. | 2013 | — |
| +1 | K033913 | Progreat | Terumo Medical Corp. | 2004 | — |
| +1 | K133447 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres | Celonova Biosciences, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 NAJ? 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 NAJ device
- #1 K233813 Bearing nsPVA Express™score 8.3 · 7 generations · no Class I recall
What was it cleared against? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K871047 | Radiopaque Spherical Emboli (Rse)Summary page 1…Classification Name: Artificial Embolization Device and Intravascular I n lu si o n Cat hc t er Katne of ContourO Emboli PVA (K87 1047. K 9 14806, K944354) Predicate Fas-Tracker@-325 Infusion Catheter (K926243) I)evices Embosphere Microspheres… | 1987 |
| Kept off the family tree | K914806 | FDA’s K914806 is Abuscreen (R) Ontrak (R) Positive Reference Control Our reading of the summary gave K914806, FDA’s number for Abuscreen (R) Ontrak (R) Positive Reference Control (Roche Diagnostic Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Contour Emboli PVA”. Kept off the family tree. Summary page 1…Classification Name: Artificial Embolization Device and Intravascular I n lu si o n Cat hc t er Katne of ContourO Emboli PVA (K87 1047. K 9 14806, K944354) Predicate Fas-Tracker@-325 Infusion Catheter (K926243) I)evices Embosphere Microspheres(K99 1549,… | 1991 |
| * | K944354 | Contour EmboliSummary page 1…tion Name: Artificial Embolization Device and Intravascular I n lu si o n Cat hc t er Katne of ContourO Emboli PVA (K87 1047. K 9 14806, K944354) Predicate Fas-Tracker@-325 Infusion Catheter (K926243) I)evices Embosphere Microspheres(K99 1549, K02 1397)… | 1994 |
| Kept off the family tree | K926243 | FDA’s K926243 is Angiographic Catheter Our reading of the summary gave K926243, FDA’s number for Angiographic Catheter (Target Therapeutics). Its FDA name has none of the distinctive words the summary uses for the device it names, “Fas-Tracker-325 Infusion Catheter”. Kept off the family tree. Summary page 1…I n lu si o n Cat hc t er Katne of ContourO Emboli PVA (K87 1047. K 9 14806, K944354) Predicate Fas-Tracker@-325 Infusion Catheter (K926243) I)evices Embosphere Microspheres(K99 1549, K02 1397) EmboGold Microspheres (KO 10026) Classific… | 1993 |
| * | K991549 | Embosphere MicrospheresSummary page 1…ContourO Emboli PVA (K87 1047. K 9 14806, K944354) Predicate Fas-Tracker@-325 Infusion Catheter (K926243) I)evices Embosphere Microspheres(K99 1549, K02 1397) EmboGold Microspheres (KO 10026) Classification Class 111, Contour@ Emboli PVA… | 2000 |
| * | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationSummary page 1…ContourO Emboli PVA (K87 1047. K 9 14806, K944354) Predicate Fas-Tracker@-325 Infusion Catheter (K926243) I)evices Embosphere Microspheres(K99 1549, K02 1397) EmboGold Microspheres (KO 10026) Classification Class 111, Contour@ Emboli PVA Cl… | 2002 |
| * | K010026 | Embogold Microsphere | 2001 |
What descends from it? (18)
See all 186 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K034068 | Contour SE Microspheres | 2004 | 10 |
| K033913 | Progreat | 2004 | 3 |
| K133447 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres | 2014 | 2 |
| K100663 | Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321 | 2010 | 2 |
| K061790 | Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization Particles | 2006 | 1 |
| K081768 | Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 17, 2009 | Not classified | Z-2109-2009 | Process design | Compromised sterility: Boston Scientific is initiating a Recall Removal for twenty (20) UPN codes and 638 associated lots/batches of its Contour SE Microspheres product. All affected product is packaged within a vial. Boston Scientific… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K034068 (Boston Scientific Corp, 2004) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K871047.
How does its category compare?
All NAJ devicesNAJ Agents, Embolic, For Treatment Of Uterine Fibroids: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NAJ
Too few NAJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NAJ
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAJ
3in 2025
MAUDE reports naming product code NAJ, 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 | 0 | — | 0 | 46 |
| 2008 | 1 | — | 0 | 23 |
| 2009 | 0 | — | 1 | 11 |
| 2010 | 1 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 21 |
| 2013 | 1 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Contour Emboli PVA are used for the embolization of hypervascular tumors, leiomyoma uteri, and arteriovenous malformations.
The FasTracker-325 Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast, and therapeutic agents, to the peripheral and coronary vasculature. This includes the delivery of the Contour Emboli PVA to the uterine arteries for the purpose of occluding blood flow to leiomyoma uteri.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030966: Contour Emboli Pva and Fastracker-325 Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030966
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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