FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)
K Number: K993417
·
Decision Jan 21, 2000
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
19
Review Days
112
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Basic Information
- Device Name
- GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)
- K Number
- K993417
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific, Target
- Date Received
- October 1, 1999
- Decision Date
- January 21, 2000
- Product Code
- HCG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | FDA class 2 | Neurology |
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Other Clearances by Boston Scientific, Target
| K Number | Device Name | ||
|---|---|---|---|
| K031049 | GUGLIELMI DETACHABLE COIL (GDC) | Aug 1, 2003 | Substantially Equivalent |
| K031168 | MATRIX STRETCH RESISTANT DETACHABLE COIL | May 14, 2003 | Substantially Equivalent |
| K030475 | GDC STRETCH RESISTANT DETACHABLE COIL | Mar 14, 2003 | Substantially Equivalent |
| K022860 | ATLANTIS PV IMAGING CATHETER, MODEL 36456 | Nov 21, 2002 | Substantially Equivalent |
| K022357 | TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 | Oct 16, 2002 | Substantially Equivalent |
| K021494 | GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 | Jun 6, 2002 | Substantially Equivalent |
| K014109 | IN-TIME RETRIEVAL DEVICE | Mar 12, 2002 | Substantially Equivalent |
| K012985 | MATRIX DETACHABLE COILS | Jan 31, 2002 | Substantially Equivalent |
| K013789 | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 | Dec 6, 2001 | Substantially Equivalent |
| K010853 | GUIDER SOFTIP GUIDING CATHETER XF 5F | Apr 18, 2001 | Substantially Equivalent |