510(k) K120872 ยท FPA Set, Administration, Intravascular
ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS
| Applicant | Unomedical A/S Infusion Devices, Osted, DK |
| Decision | Substantially Equivalent, Apr 20, 2012 |
| Received | Mar 22, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120872
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4)
Manufactured for:
Asante Solutions
Sunnyvale, CA;
Manufactured by:
Uno Terminated |
FPA | None listed |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4).
Manufactured for:
Asante Solutions
Sunnyvale, CA;
Manufactured by:
Un Terminated |
FPA | None listed |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4).
Manufactured for:
Asante Solutions
Sunnyvale, CA;
Manufactured by:
U Terminated |
FPA | None listed |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4).
Manufactured for:
Asante Solutions
Sunnyvale, CA;
Manufactured by Terminated |
FPA | None listed |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4);
Distributed by Asante Solutions,
Sunnyvale, CA;
Manufactured by Convatec Terminated |
FPA | None listed |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4)
Distributed by Asante Solutions,
Sunnyvale, CA;
Manufactured by Convate Terminated |
FPA | None listed |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4)
Distributed by Asante Solutions,
Sunnyvale, CA;
Manufactured by Convatec;
Lejre Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.