MODIFIED CONCENTRIC MICROCATHETER
FDA 510(k) clearance K131437 · decided 2013-10-11
Clearance details
- K-number
- K131437
- Device name
- MODIFIED CONCENTRIC MICROCATHETER
- Applicant
- Concentric Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-05-20
- Decision date
- 2013-10-11
- Days to decision
- 144 days
- Clearance type
- Traditional
- 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 |
| Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm recall (Z-1084-2024) | Stryker, Inc. | 2024-02-14 |