FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
K Number: K140318
·
Decision Mar 12, 2014
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
77
Applicant Total
3
Review Days
30
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Basic Information
- Device Name
- SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
- K Number
- K140318
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosense Webster
- Date Received
- February 10, 2014
- Decision Date
- March 12, 2014
- Product Code
- OBJ
- 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 |
|---|---|---|---|
| OBJ | Catheter, Ultrasound, Intravascular | FDA class 2 | Cardiovascular |
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