FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETER TUNNELER
K Number: K972555
·
Decision Dec 22, 1997
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
301
Applicant Total
4
Review Days
168
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Basic Information
- Device Name
- CATHETER TUNNELER
- K Number
- K972555
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gerard Medical, Inc.
- Date Received
- July 7, 1997
- Decision Date
- December 22, 1997
- 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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