Company
Therakos Inc
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LNR | System, Photopheresis, Extracorporeal | 8 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2021 | Therakos, Inc. THERAKOS CELLEX Photopheresis Procedural Kit
PRODUCT CODE: CLXUSA Open, Classified |
LNR | None listed |
| Dec 21, 2015 | Therakos Inc The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA.
Manufacturing lot D342
UDI: 20705030200003
The system designed to separate the patient's blood into various fraction Terminated |
LNR | None listed |
| Jan 11, 2012 | Therakos, Inc. Therakos Cellex Photopheresis System
CellexUSA & Cellex.
The photopheresis system is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug 8-methoxypsoralen Terminated |
LNR | None listed |
| Aug 10, 2011 | Therakos, Inc. XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT
Single-use, disposable, closed system with sterile flu Terminated |
LNR | None listed |
| Jul 19, 2011 | Therakos Inc Therakos Cellex Procedural Kits.
Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit. Terminated |
LNR | None listed |
| Apr 28, 2011 | Therakos Inc Therakos UVAR XTS Procedural Kits
Is indicated for use in the ultraviolet-A (UVA) irradiation. Terminated |
LNR | None listed |
| May 26, 2010 | Therakos Inc Therakos CellEx Photopheresis System;
Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument; Terminated |
LNR | None listed |
| Sep 14, 2006 | Therakos Inc Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125) Terminated |
LNR | None listed |