510(k) K192370 ยท DXT Injector And Syringe, Angiographic
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
| Applicant | Bayer Medical Care, Inc., Whippany NJ, US |
| Decision | Substantially Equivalent, Dec 13, 2019 |
| Received | Aug 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2020 | Bayer Medical Care, Inc. Brand Name: MEDRAD Stellant FLEX Syringe Kits
Common Name: Angiographic Syringe
Catalog/REF Number: FLEXD-150-SCS
Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.