510(k) K133177 ยท DQY Catheter, Percutaneous
MODIFIED HD GUIDE CATHETER
| Applicant | Concentric Medical, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Feb 25, 2014 |
| Received | Oct 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133177
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2024 | Stryker Neurovascular DAC 044 115cm, Catalog: 90760 Open, Classified |
DQY | None listed |
| May 1, 2024 | Stryker Neurovascular The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophil Open, Classified |
DQY | None listed |
| Oct 9, 2015 | Concentric Medical Inc Distal Access Catheters - 044 - 115 cm:
Finished Good Number 90960-001 / REF 90960.
Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlus Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.