FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
EQUINOX OCCLUSION BALLOON SYSTEM
K Number: K990487
·
Decision Aug 31, 1999
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
89
Applicant Total
51
Review Days
196
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Basic Information
- Device Name
- EQUINOX OCCLUSION BALLOON SYSTEM
- K Number
- K990487
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Micro Therapeutics, Inc.
- Date Received
- February 16, 1999
- Decision Date
- August 31, 1999
- Product Code
- MJN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| MJN | Catheter, Intravascular Occluding, Temporary | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| 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 |