FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K Number: K032390
·
Decision Aug 29, 2003
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
74
Applicant Total
95
Review Days
25
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Basic Information
- Device Name
- MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
- K Number
- K032390
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5120
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ebi, L.P.
- Date Received
- August 4, 2003
- Decision Date
- August 29, 2003
- Product Code
- BSO
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSO | Catheter, Conduction, Anesthetic | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K093880 | PEANUT GROWTH CONTROL PLATING SYSTEM | Apr 16, 2010 | Substantially Equivalent |
| K092574 | ESL SPINAL SYSTEM | Feb 4, 2010 | Substantially Equivalent |
| K093057 | BIOMET VISION FOOTRING SYSTEM | Dec 1, 2009 | Substantially Equivalent |
| K092336 | C-THRU SPINAL SYSTEM | Oct 15, 2009 | Substantially Equivalent |
| K091381 | IBEX SPINAL SYSTEM | Aug 7, 2009 | Substantially Equivalent |
| K090203 | 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS | Jul 30, 2009 | Substantially Equivalent |
| K090523 | POLARIS SPINAL SYSTEM | Jul 1, 2009 | Substantially Equivalent |
| K082406 | EXPANDABLE PEEK-OPTIMA IMPLANT | Jan 14, 2009 | Substantially Equivalent |