510(k) K113260 ยท DQO Catheter, Intravascular, Diagnostic
MODIFIED CONCENTIRC MICROCATHETER
| Applicant | Concentric Medical, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Mar 9, 2012 |
| Received | Nov 4, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113260
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2024 | Stryker Neurovascular Trevo Pro 14 Microcatheter, Catalog: 90231;
Trevo Pro 18 Microcatheter, Catalog: 90238 Open, Classified |
DQO | None listed |
| 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 |
| Nov 28, 2017 | Stryker Neurovascular Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter Terminated |
NRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.