510(k) K151667 ยท DQY Catheter, Percutaneous
AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
| Applicant | Stryker, Fremont CA, US |
| Decision | Substantially Equivalent, Nov 13, 2015 |
| Received | Jun 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151667
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2017 | Stryker Neurovascular Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M Terminated |
NRY | None listed |
| Dec 5, 2017 | Stryker Neurovascular Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 Terminated |
NRY | None listed |
| Dec 5, 2017 | Stryker Neurovascular Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068
Stroke intervention kit Terminated |
NRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.