510(k) K203069 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
HydroMID
| Applicant | Access Vascular, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Feb 8, 2021 |
| Received | Oct 9, 2020 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K203069
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2023 | Access Vascular, Inc HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy
Product Model Number: 80004004 Open, Classified |
FOZ | None listed |
| Feb 22, 2023 | Access Vascular, Inc HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy
Product Number: 80004004 Open, Classified |
FOZ | None listed |
| Feb 10, 2023 | Access Vascular, Inc HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 Open, Classified |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.