510(k) K162181 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
| Applicant | Cardiacassist, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Jan 6, 2017 |
| Received | Aug 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162181
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2021 | Cardiac Assist, Inc Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization.
Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17
Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15
Catalog #: 5 Terminated |
DRE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.