Sirtex Medical, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Sirtex Medical, Inc.”, plus 2 PMA decisions, across 2 product codes in 2 review panels. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NAW | Microspheres Radionuclide | 1 | 0 |
| QVG | Embolization Agent, Vascular | 1 | 0 |
Review panels
- Cardiovascular (1)
- Radiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P220020 | PMA | Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit | 2023-04-04 |
| P990065 | PMA | SIR-SPHERES | 2002-03-05 |
Recalls
openFDA lists no recalls under a recalling firm named Sirtex Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Sirtex Medical, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT05967143: Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry) (Recruiting, started 2023-06-19)
- NCT04736121: Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients (Active not recruiting, started 2021-05-28)
- NCT01721954: FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer (Completed, started 2013-05-01)
- NCT00724503: FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer (Completed, started 2006-08)
- NCT00867750: SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma (Completed, started 2006-03)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sirtex Medical US Holdings, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sirtex Medical, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Sirtex Medical, Inc.”, plus 2 PMA decisions, across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Sirtex Medical, Inc.?
The most frequent FDA product codes under this applicant name are NAW (Microspheres Radionuclide, 1); QVG (Embolization Agent, Vascular, 1).
Next steps
- See all 0 Sirtex Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NAW, Sirtex Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.