Althin Medical AB an Affiliate of Baxter Intl
Miami Lakes, FL, US
Althin Medical AB an Affiliate of Baxter Intl appears in FDA device records in Miami Lakes, FL. FDA records list 27 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Althin Medical AB an Affiliate of Baxter Intl between 1991 and 1999. The busiest year on record is 1995, with 17. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 2 |
| 1995 | 17 |
| 1996 | 2 |
| 1997 | 3 |
| 1998 | 2 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K990643 | PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 | KDI | Substantially Equivalent | |
| K970681 | ALTRA NOVA 200 HEMODIALYZER | MSF | Substantially Equivalent | |
| K970679 | ALTRA FLUX 200 HEMODIALYZER | MSF | Substantially Equivalent | |
| K970446 | DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM | KDI | Substantially Equivalent | |
| K964922 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM | KDI | Substantially Equivalent | |
| K955384 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION | KDI | Substantially Equivalent | |
| K962309 | ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS | FJI | Substantially Equivalent | |
| K954987 | ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM | KDI | Substantially Equivalent | |
| K952983 | ALTR NOVA 110 HEMODIALYZER | KDI | Substantially Equivalent | |
| K952982 | ALTREX 110 HEMODIALYZER | KDI | Substantially Equivalent | |
| K952978 | ALTRA FLUX 110 HEMODIALYZER | KDI | Substantially Equivalent | |
| K945625 | ALTRA NOVA(TM) 140 HEMODIALYZER | KDI | Substantially Equivalent | |
| K945621 | ALTRA NOVA(TM) 170 HEMODIALYZER | KDI | Substantially Equivalent | |
| K945622 | MCA(TM) 180 HEMODIALYZER | FJI | Substantially Equivalent | |
| K945542 | ALTRA FLUX(TM) 170 HEMODIALYZER | KDI | Substantially Equivalent | |
| K945631 | 155 SCE(TM) HEMODIALYZER | FJI | Substantially Equivalent | |
| K945624 | MCA(TM) 160 HEMODIALYZER | FJI | Substantially Equivalent | |
| K945623 | MCA(TM) 130 HEMODIALYZER | FJI | Substantially Equivalent | |
| K945620 | ALTRA FLUX(TM) 140 HEMODIALYZER | KDI | Substantially Equivalent | |
| K945597 | ALTRES(R) 170 HEMODIALYZER | KDI | Substantially Equivalent | |
| K945596 | ALTRES(R) 140 HEMODIALYZER | KDI | Substantially Equivalent | |
| K945595 | ALTREX(R) 200 HEMODIALYZER | KDI | Substantially Equivalent | |
| K926379 | ALTRA NOVA 200 HEMODAILYZER | KDI | Substantially Equivalent | |
| K926373 | ALTRA FLUX 200 HEMODIALYZER | KDI | Substantially Equivalent | |
| K926372 | MCA 200 HEMPDIALYZER | FJI | Substantially Equivalent | |
| K913950 | DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY | KDI | Substantially Equivalent | |
| K913526 | SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS | FJK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain