FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURECATH-ITP PERCUTANEOUS ACCESS KIT
K Number: K872149
·
Decision Aug 4, 1987
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
285
Applicant Total
3
Review Days
61
Basic Information
- Device Name
- SURECATH-ITP PERCUTANEOUS ACCESS KIT
- K Number
- K872149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- TITAN MEDICAL, INC.
- Date Received
- June 4, 1987
- Decision Date
- August 4, 1987
- Product Code
- LJT
- 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | FDA class 2 | General Hospital |
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