IVAC NEEDLE FREE VALVE ADMINISTRATION SETS
FDA 510(k) clearance K960280 · decided 1996-04-04
Clearance details
- K-number
- K960280
- Device name
- IVAC NEEDLE FREE VALVE ADMINISTRATION SETS
- Applicant
- Y
- Decision
- Substantially Equivalent
- Date received
- 1996-01-19
- Decision date
- 1996-04-04
- Days to decision
- 76 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 |
|---|---|---|
| SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications throug recall (Z-0221-2016) | CareFusion 303, Inc. | 2015-11-05 |
| SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are use recall (Z-1053-2015) | CareFusion 303, Inc. | 2015-02-04 |
| SmartSite Extension Set, Model No. 20029E, intravascular administration set. recall (Z-1459-2014) | CareFusion 303, Inc. | 2014-04-16 |
| SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are st recall (Z-0925-2014) | CareFusion 303, Inc. | 2014-02-03 |