510(k) K033892 ยท FPA Set, Administration, Intravascular
ULTRAFLEX INFUSION SET
| Applicant | Disetronic Medical Systems AG, Burgdorf, SE |
| Decision | Substantially Equivalent, Mar 9, 2004 |
| Received | Dec 16, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033892
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Catalog Number INF 04540786001. Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Distributed U.S. and Canada) and Ref No. 04626478001 (Distributed outside the U.S. only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540824001. Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540867001. Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540883001 (Distributed U.S. and Canada) and Ref. No 04626524001 (Distributed outside of the the U.S. only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540905001. Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 8 mm 24'' (60 cm); Catalog number INF 04540921001. Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540930001. Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540948001. Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540956001. Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540964001. Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540972001. Terminated |
LZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.