510(k) K152876 ยท DQY Catheter, Percutaneous
LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM
| Applicant | Tni Manufacturing, Inc., Sunrise FL, US |
| Decision | Substantially Equivalent, Jan 8, 2016 |
| Received | Sep 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152876
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2018 | Stryker Neurovascular AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.