FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
K Number: K140329
·
Decision May 15, 2014
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
174
Applicant Total
58
Review Days
94
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Basic Information
- Device Name
- RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
- K Number
- K140329
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific
- Date Received
- February 10, 2014
- Decision Date
- May 15, 2014
- Product Code
- KRA
- 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 |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
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