FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FX DETACHABLE COIL SYSTEM
K Number: K060747
·
Decision Apr 24, 2007
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
51
Review Days
400
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FX DETACHABLE COIL SYSTEM
- K Number
- K060747
- 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
- March 20, 2006
- Decision Date
- April 24, 2007
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HCG), ordered by most recent decision date.
Numen Helia Coil Embolization System; NumenFR Detachment System
FDA 510(k)
FDA Class 2
·Neurology
Optima Coil System (OptiOne Coil System)
FDA 510(k)
FDA Class 2
·Neurology
Target Detachable Coil
FDA 510(k)
FDA Class 2
·Neurology
InZone IST Detachment System; IZDS Connecting Cable
FDA 510(k)
FDA Class 2
·Neurology
Optima Coil System (Optima Packing Coil System)
FDA 510(k)
FDA Class 2
·Neurology
Numen Coil Embolization System; NumenFR Detachment System
FDA 510(k)
FDA Class 2
·Neurology
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 |
| 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 |
| K050543 | NEXUS DETACHABLE COIL SYSTEM | Apr 27, 2005 | Substantially Equivalent |