510(k) K153729 ยท DQY Catheter, Percutaneous
8F FlowGate2 Balloon Guide Catheter
| Applicant | Concentric Medical, Mountain View CA, US |
| Decision | Substantially Equivalent, Jan 27, 2016 |
| Received | Dec 28, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153729
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2024 | Stryker Neurovascular FlowGate2 8F x 85cm, Catalog: 90485
FlowGate2 8F x 95cm, Catalog: 90495 Open, Classified |
DQY | None listed |
| Jul 28, 2018 | Stryker Neurovascular FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size) Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.