Product code NAW ยท Class 3
Microspheres Radionuclide
0510(k)s in 12 months (0 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in NAW
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 0 | 2 |
| Biocompatibles U.K., Ltd. | 0 | 1 |
| MDS Canada Inc. DBA MDS Nordion | 0 | 1 |
| Sirtex Medical Limited | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2021 | Boston Scientific Corporation TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE) Open, Classified |
NAW | None listed |
| Aug 19, 2021 | Boston Scientific Corporation TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) Open, Classified |
NAW | None listed |
| Sep 21, 2015 | Biocompatibles U.K., Ltd. TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION
TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have Terminated |
NAW | None listed |
| Apr 23, 2013 | Sirtex Medical Limited Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001.
Indicated for the treatment of unresectable metastatic liver tumors. Terminated |
NAW | None listed |
| Jun 5, 2009 | MDS Canada Inc. DBA MDS Nordion TheraSphere Administration Set (Part Number K125914-034).
TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellul Terminated |
NAW | None listed |
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