INTRAVASCULAR ADMINISTRATION SET
FDA 510(k) clearance K820278 · decided 1982-02-18
Clearance details
- K-number
- K820278
- Device name
- INTRAVASCULAR ADMINISTRATION SET
- Applicant
- Y
- Decision
- Substantially Equivalent
- Date received
- 1982-02-02
- Decision date
- 1982-02-18
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer recall (Z-2281-2013) | CareFusion 303, Inc. | 2013-09-26 |