510(k) K885179 ยท DYB Introducer, Catheter
INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD
| Applicant | Baxter Healthcare Corp, Santa Ana CA, US |
| Decision | Substantially Equivalent, Aug 9, 1989 |
| Received | Dec 14, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885179
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2025 | MEDLINE INDUSTRIES, LP - Northfield CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating. Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.