MODIFIED CONCENTIRC MICROCATHETER
FDA 510(k) clearance K113260 · decided 2012-03-09
Clearance details
- K-number
- K113260
- Device name
- MODIFIED CONCENTIRC MICROCATHETER
- Applicant
- Concentric Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-04
- Decision date
- 2012-03-09
- Days to decision
- 126 days
- Clearance type
- Special
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238 recall (Z-1904-2024) | Stryker Neurovascular | 2024-05-28 |
| Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior( recall (Z-0275-2018) | Stryker Neurovascular | 2017-12-05 |
| Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM recall (Z-0276-2018) | Stryker Neurovascular | 2017-12-05 |
| Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior recall (Z-0277-2018) | Stryker Neurovascular | 2017-12-05 |