FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BULLETT PERIPHERAL INFUSION CATHETER
K Number: K931027
·
Decision Feb 4, 1994
Classifications
1
FEI Numbers
212
Registration Numbers
213
Same Product Code
496
Applicant Total
4
Review Days
340
Basic Information
- Device Name
- BULLETT PERIPHERAL INFUSION CATHETER
- K Number
- K931027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CARDIO-DYNAMICS, INC.
- Date Received
- March 1, 1993
- Decision Date
- February 4, 1994
- Product Code
- FOZ
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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