510(k) K921860 ยท FPA Set, Administration, Intravascular
MODIFICATION TO IV SPIKE
| Applicant | Mcgaw, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 30, 1992 |
| Received | Mar 11, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921860
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2013 | B. Braun Medical, Inc. Outlook Safety Infusion System Burette Set.
For intravenous fluid administration. Terminated |
FRN | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product is shipped 20 units per carton. The product i Terminated |
FRN | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Saf Terminated |
FRN | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Safeline Metriset w/Cassette, inj sties, clamps LL 114 in. Item/Catalog number 375122. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Out Terminated |
FRN | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 in US1540. Item/Catalog number 375137. The product is shipped 20 units per carton. The product is for use afte Terminated |
FPA | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Burette Set w/150 ml burette w/15 um filter & inj site, inj site, with automatic shutoff 87 in. Item/Catalog number 375113. The product is shipped 20 units per carton. The product is for use after ac Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.