EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
FDA 510(k) clearance K013789 · decided 2001-12-06
Clearance details
- K-number
- K013789
- Device name
- EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
- Applicant
- Boston Scientific, Target
- Decision
- Substantially Equivalent
- Date received
- 2001-11-14
- Decision date
- 2001-12-06
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Product is manufac recall (Z-0498-2014) | Stryker Neurovascular | 2013-12-13 |