GDC 360 DETEACHABLE COIL
FDA 510(k) clearance K103355 · decided 2011-02-16
Clearance details
- K-number
- K103355
- Device name
- GDC 360 DETEACHABLE COIL
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2010-11-16
- Decision date
- 2011-02-16
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- HCG
- Device class
- 2
- Regulation number
- 882.5950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360 Detachable Coils are intended for embolization of t recall (Z-0478-2015) | Stryker Neurovascular | 2014-12-16 |
| GDC-10 360 10mm x 30cm SR ; GDC 360 Detachable Coils are intended for embolization of thos recall (Z-0479-2015) | Stryker Neurovascular | 2014-12-16 |
| GDC-18 360 20mm x 33cm ; GDC 360 Detachable Coils are intended for embolization of those i recall (Z-0480-2015) | Stryker Neurovascular | 2014-12-16 |