510(k) K100704 ยท FRN Pump, Infusion
ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE
| Applicant | Disetronic Medical Systems AG, Indianapolis IN, US |
| Decision | Substantially Equivalent, May 14, 2010 |
| Received | Mar 12, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100704
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511046001. AC FLEXLINK PLUS 6MM CANNULA.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage in Terminated |
FRN | None listed |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511054001. AC FLEXLINK PLUS 8MM CANNULA.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage in Terminated |
FRN | None listed |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK PLUS 10MM CANNULA.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage in Terminated |
FRN | None listed |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510970001. AC FLEXLINK PLUS INF 6/40 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage i Terminated |
FRN | None listed |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510988001. AC FLEXLINK PLUS SET 6/70 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage Terminated |
FRN | None listed |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510961001. AC FLEXLINK PLUS SET 6/100 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage Terminated |
FRN | None listed |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511003001. AC FLEXLINK PLUS SET 8/40 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage Terminated |
FRN | None listed |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511020001. AC FLEXLINK PLUS SET 8/70 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage i Terminated |
FRN | None listed |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510996001. AC FLEXLINK PLUS SET 8/100 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage Terminated |
FRN | None listed |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510945001. AC FLEXLINK PLUS SET 10/40 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage i Terminated |
FRN | None listed |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510953001. AC FLEXLINK PLUS SET 10/70 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage Terminated |
FRN | None listed |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510937001. AC FLEXLINK PLUS SET 10/100 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage Terminated |
FRN | None listed |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511089001.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps.
Made in Germany
Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.