FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FARADRIVE Steerable Sheath
K Number: K233248
·
Decision Dec 11, 2023
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
40
Applicant Total
231
Review Days
74
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Basic Information
- Device Name
- FARADRIVE Steerable Sheath
- K Number
- K233248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1280
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- September 28, 2023
- Decision Date
- December 11, 2023
- Product Code
- DRA
- 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 |
|---|---|---|---|
| DRA | Catheter, Steerable | FDA class 2 | Cardiovascular |
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