510(k) K183036 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Dilator Sets
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Dec 20, 2018 |
| Received | Nov 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2024 | Cook Incorporated Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary a Open, Classified |
FGE | None listed |
| Apr 12, 2024 | Cook Incorporated Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the Open, Classified |
FGE | None listed |
| Apr 12, 2024 | Cook Incorporated Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary an Open, Classified |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.