SOLUTION ADMINISTRATION SETS
FDA 510(k) clearance K860272 · decided 1986-03-18
Clearance details
- K-number
- K860272
- Device name
- SOLUTION ADMINISTRATION SETS
- Applicant
- Travenol Laboratories, S.A.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-27
- Decision date
- 1986-03-18
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Deerfield, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Baxter Interlink System Vented Continu-Flo Solution Set, 100" (2.5 m), Vol. 2.9 mL, 3 Inje recall (Z-0472-2012) | Baxter Healthcare Corp. | 2012-01-11 |
| Baxter Interlink System Y-Type Solution Set, 78" (2.0 m), 2 Injection Sites, Male Luer Loc recall (Z-0473-2012) | Baxter Healthcare Corp. | 2012-01-11 |
| Baxter Minivolume Extension Set, 72'', product code 2C5687; An Rx sterile, nonpyrogenic fl recall (Z-1425-05) | Baxter Healthcare Corp. | 2005-08-30 |
| Baxter Minivolume Extension Set, 36'', product code 2C5685; An Rx sterile, nonpyrogenic fl recall (Z-1426-05) | Baxter Healthcare Corp. | 2005-08-30 |
| Baxter Mini-Infuser Microbore Extension Set, product code 2C9201; An Rx sterile, nonpyroge recall (Z-1427-05) | Baxter Healthcare Corp. | 2005-08-30 |
| Baxter Solution Set, 10 drops/mL, 101'', Male Luer Lock Adapter, catalog 1C8109; Baxter He recall (Z-1150-03) | Baxter Healthcare Corp. | 2003-08-21 |