# K030966: Contour Emboli Pva and Fastracker-325 Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 23, 2003 after 180 days
- Product code: NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K961923 (1996). 7 ancestors in all.
18 later devices descend from it; 6 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871047: Radiopaque Spherical Emboli (Rse), Interventional Therapeutics Corp. (1987) Summary page 1.
- K944354: Contour Emboli, Interventional Therapeutics Corp. (1994) Summary page 1.
- K991549: Embosphere Microspheres, Biosphere Medical (2000) Summary page 1.
- K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization, Biosphere Medical, Inc. (2002) Summary page 1.
- K010026: Embogold Microsphere, Biosphere Medical, Inc. (2001)

## Cited in the summary but kept off the family tree
- K914806: Abuscreen (R) Ontrak (R) Positive Reference Control, Roche Diagnostic Systems, Inc. (1991). 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.
- K926243: Angiographic Catheter, Target Therapeutics (1993). 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.

## Most influential descendants
- K034068: Contour SE Microspheres (2004), 10 descendants of its own
- K073417: Embozene Microspheres (2008), 6 descendants of its own
- K132675: Embozene Microspheres (2013), 4 descendants of its own
- K033913: Progreat (2004), 3 descendants of its own
- K133447: Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres (2014), 2 descendants of its own

## Recalls of this device
- Aug 17, 2009 · Not classified · Z-2109-2009: 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 packag

## Indications for use
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.

Source page: https://510kreport.com/device/K030966
Methodology: https://510kreport.com/methodology