510(k) K915571 ยท FPA Set, Administration, Intravascular
CLAVE CONNECTOR
| Applicant | Icu Medical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 21, 1992 |
| Received | Dec 12, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915571
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2003 | Abbott Laboratories HPD/ADD Vented and Non-Vented Burette I.V. Gravity Feed Administration Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 15 different sets listed in the code information Terminated |
FPA | None listed |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD I.V. Extension Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 22 different sets listed in the code information section below. Please Note: items p, q & r (li Terminated |
FPA | None listed |
| Jun 5, 2003 | Abbott Laboratories HPD/ADD LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE Ports and Removable 4-Way High Flow Stopcock Microdrip Soluset; Product 19292; Ma Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.