510(k) K011786 ยท FMI Needle, Hypodermic, Single Lumen
VACUETTE SAFETY BLOOD COLLECTION SET
| Applicant | Greiner Vacuette North America, Inc., Baldwin MD, US |
| Decision | Substantially Equivalent, Jul 12, 2001 |
| Received | Jun 8, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011786
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2013 | Greiner Bio-One North America, Inc. VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures. Terminated |
FMI | None listed |
| May 9, 2003 | Greiner VACUETTE North America Vacuette, Safety Blood Collection Set with Luer Adapter Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.