510(k) K974764 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
INTROSYTE CATHETER
| Applicant | Becton Dickinson Infusion Therapy Systems, Inc., Sandy UT, US |
| Decision | Substantially Equivalent, Feb 26, 1998 |
| Received | Dec 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974764
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Becton Dickinson Infusion Therapy BD First PICC Introsyte-N, 1.9Fr. x 50cm Single Lumen Procedure Kit. Terminated |
FOZ | None listed |
| Jul 20, 2004 | Becton Dickinson Infusion Therapy BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile. Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.