FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
TERUMO SURFLASH SAFETY I.V. CATHETER
K Number: K122544
·
Decision Sep 5, 2012
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
13
Review Days
15
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Basic Information
- Device Name
- TERUMO SURFLASH SAFETY I.V. CATHETER
- K Number
- K122544
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Corporation
- Date Received
- August 21, 2012
- Decision Date
- September 5, 2012
- Product Code
- FOZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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