FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HR(TM) INTRAVASCULAR CATHETER
K Number: K881666
·
Decision May 6, 1988
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
66
Review Days
18
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Basic Information
- Device Name
- HR(TM) INTRAVASCULAR CATHETER
- K Number
- K881666
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Icu Medical, Inc.
- Date Received
- April 18, 1988
- Decision Date
- May 6, 1988
- 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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