510(k) K972135 ยท FPA Set, Administration, Intravascular
MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
| Applicant | P/L Biomedical, Fort Myers FL, US |
| Decision | Substantially Equivalent, Aug 26, 1997 |
| Received | Jun 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972135
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender I 13/60 10 pieces
Product Usage: Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted ind Terminated |
FPA | None listed |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender I 13/80 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independent Terminated |
FPA | None listed |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender I 13/110 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independen Terminated |
FPA | None listed |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender I 17/60 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independent Terminated |
FPA | None listed |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender I 17/80 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independent Terminated |
FPA | None listed |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender I 17/110 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independen Terminated |
FPA | None listed |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender II 13/60 10 + 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted indep Terminated |
FPA | None listed |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender II 13/80 10 + 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted indep Terminated |
FPA | None listed |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender II 13/110 10 + 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted inde Terminated |
FPA | None listed |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender II 17/60 10 + 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted indep Terminated |
FPA | None listed |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender II 17/80 10 + 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted indep Terminated |
FPA | None listed |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender II 17/110 10 + 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted inde Terminated |
FPA | None listed |
| Nov 7, 2014 | Unomedical As Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusio Terminated |
FPA | None listed |
| Nov 7, 2014 | Unomedical As AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 Terminated |
FPA | None listed |
| Nov 7, 2014 | Unomedical As Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Confor Terminated |
FPA | None listed |
| Nov 7, 2014 | Unomedical As Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.