510(k) K172468 ยท DQY Catheter, Percutaneous
091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
| Applicant | Inneuroco, Inc., Sunrise FL, US |
| Decision | Substantially Equivalent, Dec 6, 2017 |
| Received | Aug 15, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172468
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2019 | Stryker Neurovascular Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876):
a) REF: INC-11196-70, 70cm,
b) REF: INC-11196-80, 80cm,
c) REF: INC-11196-9 Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.