FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE
K Number: K063363
·
Decision May 7, 2007
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
301
Applicant Total
4
Review Days
181
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Basic Information
- Device Name
- FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE
- K Number
- K063363
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Flexicath , Ltd.
- Date Received
- November 7, 2006
- Decision Date
- May 7, 2007
- Product Code
- LJS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | FDA class 2 | General Hospital |
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