FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAPPHIRE DETACHABLE COIL SYSTEM
K Number: K030392
·
Decision Jul 21, 2003
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
51
Review Days
166
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Basic Information
- Device Name
- SAPPHIRE DETACHABLE COIL SYSTEM
- K Number
- K030392
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micro Therapeutics, Inc.
- Date Received
- February 5, 2003
- Decision Date
- July 21, 2003
- 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 Micro Therapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K113289 | ORION MICRO CATHETER | Aug 1, 2012 | Substantially Equivalent |
| K113454 | 14 WIRE STANDARD, 14 WIRE LS | Feb 24, 2012 | Substantially Equivalent |
| K090870 | ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY | May 1, 2009 | Substantially Equivalent |
| K090046 | CONCERTO DETACHABLE COIL SYSTEM | Feb 27, 2009 | Substantially Equivalent |
| K081465 | AXIUM DETACHABLE COIL SYSTEM | Aug 19, 2008 | Substantially Equivalent |
| K060747 | FX DETACHABLE COIL SYSTEM | Apr 24, 2007 | Substantially Equivalent |
| K060625 | NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR | Apr 20, 2006 | Substantially Equivalent |
| K051990 | ECHELON MICRO CATHETER | Jan 4, 2006 | Substantially Equivalent |
| K051560 | NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR | Jun 28, 2005 | Substantially Equivalent |
| K051425 | NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR | Jun 22, 2005 | Substantially Equivalent |