IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080
FDA 510(k) clearance K882302 · decided 1988-07-12
Clearance details
- K-number
- K882302
- Device name
- IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080
- Applicant
- Y
- Decision
- Substantially Equivalent
- Date received
- 1988-06-02
- Decision date
- 1988-07-12
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PO recall (Z-0350-2024) | Becton Dickinson & Company | 2023-11-17 |
| CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood pr recall (Z-0832-2013) | Carefusion 303 Inc | 2013-02-15 |