FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL
K Number: K102714
·
Decision Feb 11, 2011
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
128
Applicant Total
432
Review Days
144
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Basic Information
- Device Name
- COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL
- K Number
- K102714
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corp
- Date Received
- September 20, 2010
- Decision Date
- February 11, 2011
- Product Code
- KRD
- 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 |
|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | FDA class 2 | Cardiovascular |
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